DHSRecalls & reported problems across all models

Synthes GmbH · 57 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 296
Deaths reported: 0
Injuries reported: 44
Recalls: 0

We found 57 models of DHS by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 296 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and May 21, 2026 — classified as 44 injuries, 252 malfunctions.

The most frequently reported specific device problem is “Break” (166 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

Last 36 months. The most recent month may be incomplete.

Most reported DHS problems

Device problems

Break166
Device-Device Incompatibility44
Material Deformation32
Adverse Event Without Identified Device or Use Problem21
Material Twisted/Bent13
Failure to Cut11
Bent9
Crack6

Patient problems

No Clinical Signs, Symptoms or Conditions120
No Consequences Or Impact To Patient60
No Patient Involvement36
No Code Available25
No Known Impact Or Consequence To Patient19
Insufficient Information16
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
Nonunion/Delayed-union Bone Fracture5

DHS models

57 models, most reported first. Each model has its own page with its reports, recalls and device details.

DHS 338.31
EXTRACTOR
64 reports
DHS 338.20
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
42 reports
DHS 338.26
IMPACTOR
35 reports
DHS 338.23
Guide, surgical, instrument
26 reports
DHS 338.19
Guide, surgical, instrument
11 reports
DHS 338.28
IMPACTOR
11 reports
DHS 338.10
BIT, DRILL
10 reports
DHS 338.21
Guide, surgical, instrument
9 reports
DHS 338.302
WRENCH
8 reports
DHS 280.900
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
7 reports
DHS 338.08
WRENCH
5 reports
DHS 280.850
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
4 reports
DHS 280.950
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
3 reports
DHS 280.990
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
3 reports
DHS 338.06
WRENCH
3 reports
DHS 338.11
REAMER
3 reports
DHS 280.000
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 reports
DHS 280.100
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 reports
DHS 280.280
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 reports
DHS 280.290
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 reports
DHS 281.021
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 reports
DHS 281.102
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 reports
DHS 281.140
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 reports
DHS 281.540S
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
2 reports
DHS 338.13
REAMER
2 reports
DHS 338.22
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
2 reports
DHS 338.750
Guide, surgical, instrument
2 reports
DHS 280.050
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 280.100S
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 280.285S
DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
1 report
DHS 280.295
DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
1 report
DHS 280.295S
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 280.305
DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
1 report
DHS 280.310
DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
1 report
DHS 280.800
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 280.800S
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 280.900S
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 281.021S
DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
1 report
DHS 281.031
DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
1 report
DHS 281.031S
DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
1 report
DHS 281.060S
PLATE, FIXATION, BONE
1 report
DHS 281.100S
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 281.130
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 281.131
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 281.160
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 281.220
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 281.440
PLATE, FIXATION, BONE
1 report
DHS 281.450
PLATE, FIXATION, BONE
1 report
DHS 281.504
DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
1 report
DHS 281.520S
DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
1 report
DHS 281.840
APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
1 report
DHS 338.005
Guide, surgical, instrument
1 report
DHS 338.01
Guide, surgical, instrument
1 report
DHS 338.02
Guide, surgical, instrument
1 report
DHS 338.047
Guide, surgical, instrument
1 report
DHS 338.32
Guide, surgical, instrument
1 report
DHS 338.44
REAMER
1 report

Recent DHS adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

MalfunctionMay 21, 2026Difficult to Advance; Material Deformation
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE LAG SCREW. THE SURGEON DESCRIBED IT AS NOT FEELING QUITE RIGHT WHEN SCREWING IT IN BUT WONDERED IT JUST DUE TO THE GOOD BONE QUALITY, THEY THEN TRIED TO FIT THE DHS PLATE OVER THE SCREW AND IT WOULDN¿T FIT, THEY TOOK THE SCREW OUT AND THE TOP WHERE THEY INSERT THE SCREW DRIVER LOOKED WARPED. THEY REPLACED THE SCREW WITH A NEW ONE AND IT WORKED FINE.
Patient problems: Insufficient Information
MAUDE report 25240560 ↗
MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT DURING THE PROCEDURE, THE COUPLING SCREW BROKE OFF INSIDE THE BACK OF THE LAG SCREW WHILE INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25046863 ↗
MalfunctionApr 21, 2026Break
IT WAS REPORTED THAT DHS COUPLING SCREW THREADED TIP BROKE OFF INTO THE THREADED PORTION OF THE LAG SCREW.
Patient problems: Insufficient Information
MAUDE report 24944409 ↗
MalfunctionApr 10, 2026Break
IT WAS REPORTED ON (B)(6), 2026 THAT THE AWL HAS BROKEN TIP, AND THE INSERTION INSTRUMENT WAS BENT. NO OPERATION INVOLVED. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839267 ↗
MalfunctionApr 6, 2026Failure to Cut
IT WAS REPORTED THAT THERE WAS A DULL REAMER AND BARREL REAMERS. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793740 ↗
MalfunctionApr 6, 2026Failure to Cut
IT WAS REPORTED THAT THERE WAS A DULL REAMER AND BARREL REAMERS. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793729 ↗
MalfunctionApr 6, 2026Failure to Cut
IT WAS REPORTED THAT THE REAMER AND BARREL REAMERS WERE DULL. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793589 ↗
MalfunctionApr 6, 2026Failure to Cut
IT WAS REPORTED THAT THE REAMER AND BARREL REAMERS WERE DULL. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793587 ↗
MalfunctionMar 24, 2026Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENTS WERE UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672974 ↗
MalfunctionMar 24, 2026Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENTS WERE UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672969 ↗
MalfunctionMar 24, 2026Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT THE INSTRUMENTS WERE UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672967 ↗
MalfunctionMar 10, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DHS SCREW INSERTER WAS BENT SO IT DID NOT CAPTURE THE SCREW. THEREFORE IT COULD NOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24558348 ↗
MalfunctionMar 10, 2026Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE DHS SCREW INSERTER WAS BENT SO IT DID NOT CAPTURE THE SCREW. THEREFORE IT COULD NOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24558347 ↗
MalfunctionFeb 6, 2026Break
IT WAS REPORTED THAT THE COUPLING SCREW TIP BROKE INTRAOPERATIVELY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. NO FRAGMENTS WERE GENERATED, AND THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280772 ↗
MalfunctionJan 13, 2026Break; Material Twisted/Bent
IT WAS REPORTED THAT MULTIPLE TRAYS HAD COMPONENTS/INSTRUMENTS THAT WERE STARTING TO BREAK APART AND SHEDDING PIECES WITH NOT IN USABLE CONDITION DURING THE SPD STERILIZATION PROCESS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059233 ↗

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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