ZipFix 08.501.001.05SRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 20887587025985), received between Dec 28, 2017 and Aug 26, 2026 — classified as 7 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (11 reports).

3 other recalls cover devices cleared under the same FDA submission (K110789); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451757 ↗
• MalfunctionAug 26, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451608 ↗
• MalfunctionAug 26, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50451607 ↗
• MalfunctionOct 1, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE STERNAL BANDS WERE NOT LOCKING. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23192776 ↗
• MalfunctionDec 11, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM INDIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE ZIPFIX IN QUESTION DID NOT TIGHTEN PROPERLY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18300871 ↗
• InjuryNov 27, 2023Device Slipped; Device Slipped

  IT WAS REPORTED ON AN UNKNOWN DATE, THERE WAS A REPORT OF FAILURE FOR THE SYNTHES STERNAL ZIPFIX. THE ZIPFIX AND STERNAL WIRES X 4 WERE IMPLANTED APPROXIMATELY 1 WEEK AGO IN A CABG, ALL 8 FAILED. THIS INFORMATION WAS GIVEN FROM THE CRNA IN THE ROOM, PERFORMING ANESTHESIA, DURING THE EXPLANTING OF HARDWARE AND STERNAL WASHOUT/DEBRIDEMENT. THE REVISION SURGERY WAS JUST PERFORMED (B)(6) 2023. THIS REPORT IS FOR STERNAL ZIPFIX NEEDLE STERILE -5PK FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18208620 ↗
• MalfunctionNov 6, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE STERNAL ZIPFIX MALFUNCTIONED DURING SURGERY. THERE WAS NO SURGICAL DELAY IN RELATION TO THE EVENT, AND NO OTHER MEDICAL INTERVENTIONS WERE REQUIRED. UPON EXAMINATION OF THE RETURNED PARTS ON (B)(6) 2023, IT WAS DETERMINED THAT ONE OF THE ZIPFIX UNITS WAS BROKEN BELOW THE LOCKING HEAD. THIS REPORT INVOLVES ONE STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072851 ↗
• MalfunctionJul 11, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED ON (B)(6)2023, THAT THE BANDS WERE NOT TIGHTENING AT THE TIME OF CLOSURE.  THE BANDS  WERE REMOVED AND DISCARDED DUE TO DOUBT OF INFECTION, AND CLOSURE OF THE STERNUM WAS CONDUCTED WITH STEEL WIRES. THERE WAS NO SURGICAL DELAY. THERE WERE NO BROKEN FRAGMENTS AND NO OTHER MEDICAL INTERVENTIONS. THE OPERATION WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) (B)(4). THIS IS REPORT 1 OF 1 FOR COMPLAINT STERNAL ZIPFIX NEEDLE STERILE -5PK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298833 ↗
• MalfunctionMar 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6), 2023, THE ZIPFIX STERNAL BANDS WERE BROKEN AT THE TIME OF CLOSURE OF THE STERNUM. THERE WAS NO SURGICAL DELAY. THE BROKEN BANDS WERE REMOVED, AND A NEW PACK WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16571959 ↗
• MalfunctionMar 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE ZIPFIX STERNAL BANDS WERE BROKEN AT THE TIME OF CLOSURE OF THE STERNUM. THERE WAS NO SURGICAL DELAY. THE BROKEN BANDS WERE REMOVED, AND A NEW PACK WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. THIS REPORT INVOLVES ONE STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16571955 ↗
• MalfunctionMar 16, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE ZIPIFIX STERNAL BANDS BROKEN IN DURING STERNUM CLOSURE. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT OUTCOME/CONSEQUENCES IS UNKNOWN. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX NEEDLE STERILE -5PK THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555448 ↗
• MalfunctionMar 16, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE ZIPIFIX STERNAL BANDS BROKEN IN DURING STERNUM CLOSURE. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. PATIENT OUTCOME/CONSEQUENCES IS UNKNOWN. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX NEEDLE STERILE -5PK THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555442 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT THE DOCTOR FOUND INFLAMMATION AROUND THE BONE WHERE ZIPFIX DEPLOYED. THERE WAS NO SUCH INFLAMMATION AROUND THE STEEL WIRE WHERE SURGEON USED IN MANUBRIUM. PATIENT DID EXPERIENCED A POST-OP DEVICE MALFUNCTION. PATIENT WAS GETTING PAIN IN THE SURGICAL SITE AND FEVER. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. DATE OF REVISION SURGERY: (B)(6) 2022. DEVICE WAS NOT EXPLANTED. PATIENT OUTCOME/ CONSEQUENCES IS UNKNOWN. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX NEEDLE STERILE -5PK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Inflammation; Pain

  MAUDE report 15876698 ↗
• MalfunctionSep 20, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON COULD NOT TIGHTEN THE ZIPFIX. A DIFFERENT DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT INVOLVES ONE STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454186 ↗
• MalfunctionSep 15, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2022, THE ZIP BANDS DID NOT FIT PROPERLY IN STERNUM CLOSURE. NO SURGICAL DELAY OR PATIENT CONSEQUENCE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15432254 ↗
• MalfunctionJun 7, 2022Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT STERNAL BANDS LOOSEN AFTER DEPLOYMENT THIS COMPLAINT INVOLVES ONE (1) DEVICE STERNAL ZIPFIX NEEDLE STERILE -5PK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14626266 ↗
• MalfunctionMay 23, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THREE ZIPFIX BAND DEVICES BROKE WHILE CLOSING THE STERNUM. THE PROCEDURE WAS COMPLETED WITH A DELAY OF TEN MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES THREE(3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14473671 ↗
• MalfunctionMay 23, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 3 FOR PC-(B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THREE ZIPFIX BAND DEVICES BROKE WHILE CLOSING THE STERNUM. THE PROCEDURE WAS COMPLETED WITH A DELAY OF TEN MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES THREE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14471040 ↗
• MalfunctionMay 23, 2022Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN INDIA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THREE ZIPFIX BAND DEVICES BROKE WHILE CLOSING THE STERNUM. THE PROCEDURE WAS COMPLETED WITH A DELAY OF TEN MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES THREE(3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14471022 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A REVISION SURGERY WAS PERFORMED DUE TO OPENING OF THE WOUND. THIS REPORT INVOLVES ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4). (B)(4) CAPTURES THE POST-OP EVENT AND (B)(4) CAPTURES THE INTRA-OPERATIVE EVENT OF THE NEEDLE BENDING.

  Patient problems: Wound Dehiscence

  MAUDE report 13769359 ↗
• MalfunctionJan 5, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE CARDIAC BYPASS THE ZIPFIX NEEDLE WAS NOT ABLE TO BE TIGHTENED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX NEEDLE STERILE -5PK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170084 ↗
• InjuryDec 17, 2019Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING: ON (B)(6) 2018, THE PATIENT PRESENTED AN INCREASED DRAINAGE FROM HIS STERNAL INCISION. HE UNDERWENT A THORACENTESIS W/ ULTRASOUND GUIDANCE OF THE LEFT CHEST WITH SUCCESSFUL THORACENTESIS YIELDING 525ML OF SEROSANGUINEOUS FLUID DONE ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT HAD CONCERNS OF A STERNAL WOUND DEHISCENCE. IT WAS NOTED THAT HIS INCISION HAS INCREASED DRAINAGE AND SOME CONCERNS FOR STERNAL DEHISCENCE. INITIALLY AFTER THE FIRST DEBRIDEMENT, THE PATIENT HAD A WOUND VAC THAT WAS APPLIED TO THE STERNAL DEFECT. HIS PREVIOUS STERNAL ZIP TIES WERE REMOVED INTRAOPERATIVELY AS THEY HAD PULLED THROUGH AND WERE NO LONGER FUNCTIONING AND THE FACT THAT THE ZIP TIES CAME UNDONE. THEY DID NOT PULL THROUGH THE ACTUAL STERNUM. ON (B)(6) 2018, THE PATIENT DEVELOPED A SUBSTERNAL INFECTION REQUIRING A DEBRIDEMENT.

  Patient problems: Necrosis; No Code Available; Unspecified Infection

  MAUDE report 9483619 ↗
• MalfunctionFeb 6, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, A STERNAL ZIPFIX WOULD NOT LOCK TO STAY IN PLACE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8311902 ↗
• MalfunctionSep 4, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018. THE STERNAL ZIPFIX TEETH MECHANISM DIDN'T CATCH AS INTENDED WHEN TIGHTENED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE BOTH UNKNOWN. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7842265 ↗
• MalfunctionJun 6, 2018Break; Break

  IT WAS REPORTED THAT DURING CLOSING OF THE STERNOTOMY AFTER PERFORMING AN AORTIC ROOT PROCEDURE ON (B)(6) 2018, THE TIE OF THE STERNAL ZIPFIX BROKE PREMATURELY WHILE BEING APPLIED WITH TENSION. THERE WERE FOUR OTHER ZIP TIES THAT WERE SUCCESSFULLY TIGHTENED AND CUT AFTER THE FIRST TIE BROKE. THE SURGEON FELT THE STERNUM WAS STABLE AND LEFT THE FIFTH POINT OF FIXATION OFF. THERE WAS NO SURGICAL DELAY REPORTED. BROKEN DEVICE WAS EASILY REMOVED. NO REPORTED PATIENT CONSEQUENCES. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: APPLICATION INSTRUMENT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7574185 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110789. One submission often covers many models, so check the product and lot details in each record.

• Z-0276-2016 · Oct 19, 2015 · Terminated
  Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum
• Z-2475-2015 · Jul 22, 2015 · Terminated
  Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to
• Z-0114-2014 · Aug 13, 2013 · Terminated
  Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to st