ZipFix 08.501.001.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10887587025971), received between Dec 15, 2017 and Aug 26, 2026 — classified as 4 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (16 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 25 most recent of 39 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 50461722 ↗
• MalfunctionAug 26, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461717 ↗
• MalfunctionAug 26, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461707 ↗
• MalfunctionJan 27, 2026Break; Mechanical Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT 1. ZIPTIE HEAD DID NOT ENGAGE WITH THE TEXTURED BODY, COULD NOT SINCH DOWN. 2. ZIPTIE SNAPPED WHEN DOCTOR WAS TENSIONING THE TIE. 1. WHEN THE DOCTOR WENT TO TENSION THE ZIPTIE, THE HEAD DID NOT ENGAGE WITH THE TEXTURED PART. WHEN HE LOOKED AT THE TIE AFTER IT LOOKED LIKE THE HEAD WAS TOO LARGE FOR THE TEETH TO GRAB ONTO ANYTHING. THEY IRRIGATED IT AND MADE SURE NO SOFT TISSUE WAS IN THE WAY AND IT STILL DID NOT ENGAGE. 2. THE OTHER ZIP TIE TIGHTENED DOWN BUT WHEN HE USED THE APPLICATOR GUN IT JUST COMPLETELY SNAPPED IN HALF. NO DIFFERENCE IN TECHNIQUE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192492 ↗
• MalfunctionJan 27, 2026Break; Mechanical Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THAT 1. ZIPTIE HEAD DID NOT ENGAGE WITH THE TEXTURED BODY, COULD NOT SINCH DOWN. 2. ZIPTIE SNAPPED WHEN DOCTOR WAS TENSIONING THE TIE. 1. WHEN THE DOCTOR WENT TO TENSION THE ZIPTIE, THE HEAD DID NOT ENGAGE WITH THE TEXTURED PART. WHEN HE LOOKED AT THE TIE AFTER IT LOOKED LIKE THE HEAD WAS TOO LARGE FOR THE TEETH TO GRAB ONTO ANYTHING. THEY IRRIGATED IT AND MADE SURE NO SOFT TISSUE WAS IN THE WAY AND IT STILL DID NOT ENGAGE. 2. THE OTHER ZIP TIE TIGHTENED DOWN BUT WHEN HE USED THE APPLICATOR GUN IT JUST COMPLETELY SNAPPED IN HALF. NO DIFFERENCE IN TECHNIQUE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192396 ↗
• MalfunctionNov 3, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE ZIPFIX BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452521 ↗
• MalfunctionSep 23, 2024Mechanical Problem; Nonstandard Device; Mechanical Problem; Nonstandard Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCT WAS DAMAGED, RIDGES NOT ON WIRE; UNABLE TO CINCH TO CLOSE. THIS REPORT IS FOR A STERNAL ZIPFIX WITH NEEDLE STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279629 ↗
• MalfunctionMay 1, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2024, THE ZIP FIX WOULD NOT TIGHTEN. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY. THIS REPORT IS FOR ONE STERNAL ZIPFIX WITH NEEDLE STERILE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19225231 ↗
• MalfunctionMay 1, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2024, THE ZIP FIX WOULD NOT TIGHTEN. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY. THIS REPORT IS FOR ONE STERNAL ZIPFIX WITH NEEDLE STERILE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19224439 ↗
• MalfunctionMay 1, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2024, THE ZIP FIX WOULD NOT TIGHTEN. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO SURGICAL DELAY. THIS REPORT IS FOR ONE STERNAL ZIPFIX WITH NEEDLE STERILE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19222990 ↗
• MalfunctionMar 5, 2024Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835911 ↗
• MalfunctionFeb 9, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED DURING A MEDIASTINAL NEOPLASM SURGERY ON (B)(6) 2024, WHILE CLOSING THE STERNUM, THE ZIPFIX WAS BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT IS FOR ONE STERNAL ZIPFIX WITH NEEDLE STERILE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677138 ↗
• MalfunctionDec 21, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THE SURGEONS WERE USING ZIPFIX TO CLOSE THE STERNUM POST HEART SURGERY DURING STERNOTOMY ON (B)(6) 2023. THEY HAD HAND TIGHTENED 3 ZIPFIX IMPLANTS INTO PLACE. DURING TENSIONING WITH THE APPLICATOR, IT WAS NOTICED THAT ONE OF THE ZIPFIX IMPLANTS WAS NOT LOCKING. SEVERAL ATTEMPTS WERE MADE TO TENSION THE ZIPFIX HOWEVER IT LOOSENED EACH TIME. THE IMPLANT WAS REMOVED AND INSPECTED. LOCKING MECHANISM NOT FUNCTIONING CORRECTLY. IMPLANT SENT TO BE CLEANED AND RETURNED FOR ASSESSMENT. NO SURGICAL DELAY WAS REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR STERNAL ZIPFIX WITH NEEDLE STERILE FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375445 ↗
• MalfunctionAug 18, 2023Migration; Migration

  THERE WAS A SLIGHT DELAY IN SURGERY DUE TO THE EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THIS REPORT IS FOR A STERNAL ZIPFIX WITH NEEDLE STERILE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17576562 ↗
• MalfunctionJul 17, 2023Device Slipped; Device Slipped

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6)2023, A STERNAL BAND CAME OUT DEFECTIVE ¿ THE BAND DID NOT SEAL AND DID NOT ADJUST. IT WAS CHANGED TO ANOTHER ONE THAT STAYED IMPLANTED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE STERNAL ZIPFIX WITH NEEDLE STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333725 ↗
• MalfunctionApr 4, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: IT WAS REPORTED THAT ON MARCH (B)(6) 2023, THE ZIPFIX WAS BROKEN OFF DURING SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS REPORT INVOLVES ONE STERNAL ZIPFIX WITH NEEDLE STERILE. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675821 ↗
• MalfunctionFeb 28, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE REPS ARE FILING A COMPLAINT ABOUT STERNAL ZIPFIX IMPLANTS THAT DID NOT LOCK PROPERLY DURING A CUSTOMER DEMONSTRATION TODAY. NO PATIENT WAS INVOLVED. REPS HAVE TWO OF THE THREE IN THEIR POSSESSION. THE OTHER WAS PUT INTO A SHARPS BIN AND WAS UNABLE TO BE RECOVERED. ALL THREE HANDLED IN THE SAME MANNER. THE TEETH DID NOT ENGAGE WITH THE TIE, AND SLID PASSIVELY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457173 ↗
• MalfunctionFeb 28, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON FEB 8, 2023, THE REPS ARE FILING A COMPLAINT ABOUT STERNAL ZIPFIX IMPLANTS THAT DID NOT LOCK PROPERLY DURING A CUSTOMER DEMONSTRATION TODAY. NO PATIENT WAS INVOLVED. REPS HAVE TWO OF THE THREE IN THEIR POSSESSION. THE OTHER WAS PUT INTO A SHARPS BIN AND WAS UNABLE TO BE RECOVERED. ALL THREE HANDLED IN THE SAME MANNER. THE TEETH DID NOT ENGAGE WITH THE TIE, AND SLID PASSIVELY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16456080 ↗
• MalfunctionFeb 28, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THE REPS ARE FILING A COMPLAINT ABOUT STERNAL ZIPFIX IMPLANTS THAT DID NOT LOCK PROPERLY DURING A CUSTOMER DEMONSTRATION TODAY. NO PATIENT WAS INVOLVED. REPS HAVE TWO OF THE THREE IN THEIR POSSESSION. THE OTHER WAS PUT INTO A SHARPS BIN AND WAS UNABLE TO BE RECOVERED. ALL THREE HANDLED IN THE SAME MANNER. THE TEETH DID NOT ENGAGE WITH THE TIE, AND SLID PASSIVELY. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455979 ↗
• MalfunctionNov 1, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022 THE ZIPFIX TIGHTENED DOWN AND CUT THEN BEGAN SLIPPING GROOVED LOCKS DID NOT HOLD. STERNAL PLATING HAD TO BE USED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A STERNAL ZIPFIX WITH NEEDLE STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15708015 ↗
• MalfunctionAug 31, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ZIP FIX NOT STAYING CLOSED. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR 1 STERNAL ZIPFIX WITH NEEDLE STERILE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327731 ↗
• MalfunctionAug 10, 2022Break; Break

  DEVICE REPORT FROM SOUTH KOREA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE FIXATION OF THE ZIPFIX WAS LOST. WHEN THE REMAINING AREA WAS CUT OFF AFTER FIXING THE ZIP, THE FIXED AREA OPENED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A DELAY OF 5 MINUTES, USING EXTRA INVENTORY FROM THE OPERATING ROOM. THERE WAS NO REPORTED ADVERSE PATIENT OUTCOME OR CONSEQUENCE. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR A STERNAL ZIPFIX WITH NEEDLE STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199044 ↗
• MalfunctionMay 11, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCT WOULD NOT LOCK. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14357012 ↗
• MalfunctionMay 4, 2020Break; Break

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON AN UNKNOWN DATE, FIVE (5) OUT OF 20/PACK STERNAL ZIPFIX WITH NEEDLE WERE NOT FASTENING CORRECTLY. THE PROCEDURE OUTCOME WAS NOT AFFECTED. SURGERY WAS DELAYED FOR APPROXIMATELY 2-5 MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE RETURNED DEVICES, IT WAS IDENTIFIED THAT ONE (1) STERNAL ZIPFIX WITH NEEDLE/SINGLE PACK WAS BROKEN. THIS PRODUCT CONDITION WAS ASSESSED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2020. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10021525 ↗
• MalfunctionApr 24, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE THE STERNAL ZIPFIX WITH NEEDLE BROKE UPON BEING PULLED ON AND WAS DISCARDED. A SECOND ZIPFIX USED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) STERNAL ZIPFIX WITH NEEDLE STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996230 ↗

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