ZipFix 08.501.001.20SRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 20887587025992), received between May 9, 2018 and Dec 22, 2025 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, IT WAS NOTED THAT THE ZIPFIX WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864290 ↗
• MalfunctionNov 11, 2025Break; Break

  IT WAS REPORTED ON (B)(6) 2025, THE PRODUCT RIPPED WHEN THEY TRIED TO PUT IT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525145 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THE ZIPFIX NEEDLE BROKE DURING STERNUM CLOSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086177 ↗
• MalfunctionMar 21, 2024Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 DURING SURGERY, THE NEEDLE ON THE PRODUCT IN QUESTION DETACHED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18953813 ↗
• MalfunctionSep 18, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ZIPFIX WAS UNLOCKED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764678 ↗
• MalfunctionSep 18, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ZIPFIX WAS UNLOCKED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764676 ↗
• MalfunctionSep 18, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ZIPFIX WAS UNLOCKED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764584 ↗
• MalfunctionApr 25, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE ZIPFIX WOULD NOT TIGHTEN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811302 ↗
• MalfunctionFeb 27, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED ON FEBRUARY 7 2023, THAT THE ZIPFIX BAND BROKE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX NEEDLE STERILE-20PK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449596 ↗
• MalfunctionJan 24, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT WHILE TIGHTENING TO CLOSE THE STERNUM (THORAX), THE 2 ZIP-FIXES BROKE. THE ZIP-FIX DID NOT CLOSE WHEN CLOSING THE STERNUM DESPITE USING THE TENSIONER. SURGERY WAS DELAYED AROUND 20 MINUTES DUE TO THE REPORTED EVENT, HOWEVER THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT HARM REPORTED. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX NEEDLE STERILE-20PK. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237165 ↗
• MalfunctionJan 24, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT WHILE TIGHTENING TO CLOSE THE STERNUM (THORAX), THE 2 ZIP-FIXES BROKE. THE ZIP-FIX DID NOT CLOSE WHEN CLOSING THE STERNUM DESPITE USING THE TENSIONER. SURGERY WAS DELAYED AROUND 20 MINUTES DUE TO THE REPORTED EVENT, HOWEVER THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT HARM REPORTED. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX NEEDLE STERILE-20PK THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237121 ↗
• MalfunctionJan 24, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT INTRAOPERATIVELY ON AN UNKNOWN DATE, WHILE TIGHTENING TO CLOSE THE STERNUM (THORAX) THE 2 ZIPFIXES BROKE AND THIRD ZIPFIX DID NOT CLOSE WHEN CLOSING THE STERNUM DESPITE USING THE TENSIONER. PROBLEM OCCURRED SEVERAL TIMES. SURGEON ENDED UP CLOSING WITH STERNAL PLATES AND SCREWS TO AVOID WOUND OPENING AND THE SURGICAL DELAY WAS AROUND TWENTY (20) MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16237086 ↗
• MalfunctionNov 29, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE, THE SURGEON COULD NOT TIGHTEN THE ZIPFIX. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR A STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15878415 ↗
• MalfunctionJan 18, 2022Break; Break

  IT WAS REPORTED THAT DURING A CABG PROCEDURE ON AN UNKNOWN DATE, A ZIPFIX NEEDLE BROKE. WHEN CLOSING THE STERNUM, THE SURGEON STARTED TO PUSH A ZIPFIX THROUGH AND THE NEEDLE BROKE OFF THE ZIP ABOUT A CENTIMETER FROM THE END OF THE NEEDLE. A NEW ZIP FIX WAS OPENED. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A STERNAL ZIPFIX WITH NEEDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13281364 ↗
• InjuryOct 19, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THAT ONE (1) OF THE CABLES HAD THE NEEDLE ATTACHED IN THE WRONG DIRECTION, THIS WAS NOT USER ERROR. IT WAS DISCOVERED WHEN ATTEMPTING TO INSERT THE CABLE INTO THE LOCKING MECHANISM. WHILE ATTEMPTING TO CLOSE THE OTHER CABLE, IT TIGHTENED FINE BUT WHEN ATTEMPTING TO USE THE TOOL TO TRIM THE EXCESS IT SHATTERED/SNAPPED AND LEFT AN INEFFECTIVE CLOSURE. ALL OF THE INITIAL TIES WERE REMOVED AND REPLACED WHICH CAUSED SOME MINOR PATIENT BLEEDING/ LOCAL TRAUMA. THERE WAS A TWENTY (20) MINUTE SURGICAL DELAY. THERE WERE NO CONSEQUENCES TO THE PATIENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX NEEDLE STERILE-20PK. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 12657775 ↗
• InjuryOct 19, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THAT ONE (1) OF THE CABLES HAD THE NEEDLE ATTACHED IN THE WRONG DIRECTION, THIS WAS NOT USER ERROR. IT WAS DISCOVERED WHEN ATTEMPTING TO INSERT THE CABLE INTO THE LOCKING MECHANISM. WHILE ATTEMPTING TO CLOSE THE OTHER CABLE, IT TIGHTENED FINE BUT WHEN ATTEMPTING TO USE THE TOOL TO TRIM THE EXCESS IT SHATTERED/SNAPPED AND LEFT AN INEFFECTIVE CLOSURE. ALL OF THE INITIAL TIES WERE REMOVED AND REPLACED WHICH CAUSED SOME MINOR PATIENT BLEEDING/ LOCAL TRAUMA. THERE WAS A TWENTY (20) MINUTE SURGICAL DELAY. THERE WERE NO CONSEQUENCES TO THE PATIENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX NEEDLE STERILE-20PK. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 12657759 ↗
• MalfunctionSep 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE ZIPFIX WAS UNLOCKED AFTER LOCKING. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475430 ↗
• MalfunctionSep 15, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A HEART VALVE REPLACEMENT, THE ZIPFIX BROKE OFF. ANOTHER ONE WAS USED TO CONTINUE THE SURGERY, HOWEVER THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474575 ↗
• MalfunctionSep 15, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A HEART VALVE REPLACEMENT, THE ZIPFIX BROKE OFF. ANOTHER ONE WAS USED TO CONTINUE THE SURGERY, HOWEVER THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474542 ↗
• MalfunctionSep 3, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2021 THE SURGEON USED STERNAL ZIPFIX FOR STERNAL CLOSURE AFTER CARDIAC SURGERY. DURING HOLDING THE ZIPFIX NEEDLE IN THE NEEDLE HOLDER, THE NEEDLE CAME OFF FROM THE BAND AND USED ANOTHER BAND TO CLOSE THE SURGERY. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421274 ↗
• MalfunctionApr 8, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, FIVE (5)STERNAL ZIPFIX WITH NEEDLE WERE NOT FASTENING CORRECTLY. THE STERNAL ZIPFIX WITH NEEDLE COME IN A PACK OF TWENTY (20). THE PROCEDURE OUTCOME WAS NOT AFFECTED. SURGERY WAS DELAYED FOR APPROXIMATELY FIVE (5) MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. THIS REPORT INVOLVES ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9935624 ↗
• InjuryMar 18, 2020Break; Break

  IT WAS REPORTED THAT DURING A REAPPROXIMATION OF THE STERNUM PROCEDURE WITH STERNUM PLATES AND SCREWS ON (B)(6) 2020, THREE STERNAL ZIPFIX WERE BROKEN. IT WAS BELIEVED THAT THE SIZE OF THE PATIENT MAY HAVE CONTRIBUTED TO THE ISSUE. THE SURGEON STATED THAT HE SHOULD HAVE USED MORE FIXATION DUE TO THE PATIENT SIZE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATENT IS RECOVERING. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNKNOWN STERNUM PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE/ 20 PACK. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9848102 ↗
• MalfunctionMay 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE SURGEON PUT THE PATIENT SAFETY & LEARNING SYSTEM (PSLS) FOR ZIPFIX IN PATIENT AND SECURED IT BUT IT CAME UNDONE. THE SURGEON WAS UNABLE TO RE-INSERT IT. A NEW ZIPFIX STRAP WAS OPENED AND THE CASE WAS COMPLETED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR STERNAL ZIPFIX WITH NEEDLE STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7500239 ↗

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