ZipFixRecalls & reported problems across all models
Synthes GmbH · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 327
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 0
We found 4 models of ZipFix by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 327 adverse event reports in the FDA's MAUDE database, received between May 20, 2014 and Aug 26, 2026 — classified as 22 injuries, 305 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (156 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ZipFix problems
Device problems
- Mechanical Problem156
- Break94
- Device Operates Differently Than Expected47
- Device-Device Incompatibility8
- Device Slipped6
- Failure to Cut6
- Mechanical Jam6
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions152
- No Consequences Or Impact To Patient65
- No Known Impact Or Consequence To Patient43
- No Patient Involvement43
- No Code Available16
- Insufficient Information7
- Not Applicable3
- Unspecified Infection3
ZipFix models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ZipFix 03.501.080CERCLAGE, FIXATION236 reports
- ZipFix 08.501.001.01SCERCLAGE, FIXATION39 reports
- ZipFix 08.501.001.05SCERCLAGE, FIXATION29 reports
- ZipFix 08.501.001.20SCERCLAGE, FIXATION23 reports
Recent ZipFix adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionFeb 5, 2026Mechanical Problem
IT WAS REPORTED THAT INSTRUMENT TIP DOES NOT ENGAGE THE ZIP TIES OR RATCHET TO TIGHTEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24270418 ↗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 ↗MalfunctionJan 27, 2026Mechanical Problem; Mechanical Jam
IT WAS REPORTED THAT A TRIGGER OF THE APPLICATION INSTRUMENT FOR STERNAL ZIPFIX WAS NOT WORKING CORRECTLY AND BECAME STUCK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24192163 ↗MalfunctionJan 27, 2026Mechanical Problem; Mechanical Jam
IT WAS REPORTED ON AN UNKNOWN DATE APPLICATION INSTRUMENTS; TRIGGER NOT WORKING CORRECTLY; GETS STUCK. THE EVENT OCCURRED IN PRE-SURGERY AND THERE WERE NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24191407 ↗MalfunctionJan 27, 2026Mechanical Problem; Mechanical Jam
IT WAS REPORTED ON AN UNKNOWN DATE APPLICATION INSTRUMENTS; TRIGGER NOT WORKING CORRECTLY; GETS STUCK. THE EVENT OCCURRED IN PRE-SURGERY AND THERE WERE NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24191406 ↗MalfunctionJan 8, 2026Mechanical Problem
IT WAS REPORTED THAT DURING A SURGERY IT WAS OBSERVED THAT THE CUTTING ARM OF APPLICATION INSTRUMENT FOR STERNAL ZIPFIX DIDN'T STAY UP AND DIDN'T ALLOW FOR TENSIONING TO WORK. THERE WAS NO PATIENT HARM. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005875 ↗MalfunctionDec 29, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE DEVICES ARE NOT PULLING CORRECTLY; STIFF. THE LEVER THAT CUTS IS VERY WOBBLY. THE ISSUE WAS OBSERVED DURING PRE-SURGERY AND NO INJURIES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905011 ↗MalfunctionDec 29, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE DEVICES ARE NOT PULLING CORRECTLY; STIFF. THE LEVER THAT CUTS IS VERY WOBBLY. THE ISSUE WAS OBSERVED DURING PRE-SURGERY AND NO INJURIES. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905004 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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