SynFrameRecalls & reported problems across all models
Synthes GmbH · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 319
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 18 models of SynFrame by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 319 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2016 and Sep 22, 2026 — classified as 2 injuries, 317 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (80 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 SynFrame problems
Device problems
- Device-Device Incompatibility80
- Compatibility Problem70
- Material Integrity Problem65
- Mechanical Problem47
- Device Operates Differently Than Expected38
- Failure To Adhere Or Bond16
- Mechanical Jam13
- Break12
Patient problems
- No Clinical Signs, Symptoms or Conditions126
- No Consequences Or Impact To Patient121
- No Known Impact Or Consequence To Patient38
- No Patient Involvement30
- Insufficient Information16
- No Code Available3
SynFrame models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SynFrame 387.347ORTHOPEDIC MANUAL SURGICAL INSTRUMENT131 reports
- SynFrame 387.337ORTHOPEDIC MANUAL SURGICAL INSTRUMENT46 reports
- SynFrame 387.358ORTHOPEDIC MANUAL SURGICAL INSTRUMENT43 reports
- SynFrame 387.346ORTHOPEDIC MANUAL SURGICAL INSTRUMENT29 reports
- SynFrame 387.345Lamp, operating-room12 reports
- SynFrame 387.334ORTHOPEDIC MANUAL SURGICAL INSTRUMENT11 reports
- SynFrame 387.338Lamp, operating-room9 reports
- SynFrame 387.343Lamp, operating-room9 reports
- SynFrame 387.336Lamp, operating-room6 reports
- SynFrame 387.344Lamp, operating-room6 reports
- SynFrame 387.353Lamp, operating-room5 reports
- SynFrame 387.361ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- SynFrame 03.612.012ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- SynFrame 387.356ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- SynFrame 387.335ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- SynFrame 387.397Lamp, operating-room1 report
- SynFrame 387.451RETRACTOR1 report
- SynFrame 387.452RETRACTOR1 report
Recent SynFrame adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858730 ↗MalfunctionSep 17, 2026Compatibility Problem; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809744 ↗MalfunctionApr 27, 2026Material Integrity Problem
IT WAS REPORTED THAT THE SYNFRAME HALF-RING WAS ALREADY BROKEN BEFORE IT COULD BE USED FOR THE OPERATING ROOM ON (B)(6) 2026. WITH SOME INGENUITY AND IMPROVISATION, THE OPERATING ROOM WAS ABLE TO PROCEED AS PLANNED AND HAD NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25004104 ↗MalfunctionApr 23, 2026Compatibility Problem; Material Integrity Problem
THE SCREW ON THE ROD GUIDE FROM THE SYNFRAME (RIGHT SIDE) IS STRIPPED. THE NURSE WAS UNABLE TO ATTACH A BLADE. THE INSTRUMENT NEEDS TO BE REPLACED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24966477 ↗MalfunctionApr 15, 2026Compatibility Problem
IT WAS REPORTED THAT THERE WAS A PRODUCT COMPATIBILITY ISSUE. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886080 ↗MalfunctionJan 5, 2026Use of Device Problem; Material Integrity Problem
IT WAS REPORTED THE CLAMP HAD A BROKEN/MISSING SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957954 ↗MalfunctionDec 17, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem
IT WAS REPORTED THAT DURING A PROCEDURE, BOTH OF THE CLAMPS WILL NO LONGER TIGHTEN. THEY WERE UNABLE TO BE USED WITH THE RETRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23832357 ↗MalfunctionDec 17, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem
IT WAS REPORTED THAT DURING A PROCEDURE, BOTH OF THE CLAMPS WILL NO LONGER TIGHTEN. THEY WERE UNABLE TO BE USED WITH THE RETRACTOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO GENERATION OF FRAGMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23832354 ↗MalfunctionSep 3, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED SYNFRAME ARM WAS BROKEN IN THE THREADED AREA THAT THE THUMB SCREW/TIGHTENING BOLT GOES IN. THERE WAS NO HARM TO THE PATIENT AND NO SURGICAL DELAY. THE PROCEDURE CONTINUED AND WAS SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22951113 ↗MalfunctionAug 27, 2025Compatibility Problem; Compatibility Problem
IT WAS REPORTED THAT THE SURGEON WAS DOING A MAS DECOMPRESSION AND THE INSTRUMENT WAS LOOSE AND OLD. ADDITIONALLY DEVICE SYNFRAME INSULATED TABLE CLAMP WAS NO LONGER PROPERLY HOLDING THE ROD. THERE WAS NO SURGICAL DELAY AND NO PATIENT IMPACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909409 ↗MalfunctionAug 26, 2025Mechanical Problem; Compatibility Problem; Mechanical Problem; Compatibility Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW WAS LOOSE ON THE SYNFRAME HOLDING RING Ø240. NO HIDER WAS ENCOUNTERED DURING THE OPERATING ROOM. IT WAS DIFFICULT TO ASSEMBLE BEFORE THE OPERATING ROOM, AND AFTER THE OPERATION, THE SCREW WAS LOOSE. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22892958 ↗MalfunctionAug 4, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT ON (B)(6) 2025 THE NUT ON THE SYNFRAME CONNECTING ROD IS STUCK FAST. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709072 ↗MalfunctionJul 31, 2025Mechanical Problem; Mechanical Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT THE ITEMS WERE FOUND NOT TO BE WORKING PRIOR TO THE CASE. THERE WAS NO PATIENT INVOLVEMENT OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22675627 ↗MalfunctionJul 31, 2025Mechanical Problem; Mechanical Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT IT WAS FOUND THAT THESE ITEMS WERE NOT WORKING PRIOR TO THE CASE. THERE WAS NO PATIENT INVOLVEMENT OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22675465 ↗MalfunctionJul 28, 2025Mechanical Problem; Material Integrity Problem; Mechanical Problem; Material Integrity Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THAT THESE WERE LOT NUMBERS OF THE PRODUCT:1050769-1 X21051599 X21649874 X2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22632792 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page