DHHSRecalls & reported problems across all models
Synthes GmbH · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 0
We found 13 models of DHHS by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2017 and Aug 6, 2025 — classified as 8 injuries, 15 malfunctions.
The most frequently reported specific device problem is “Break” (9 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 DHHS problems
Device problems
- Break9
- Device-Device Incompatibility5
- Adverse Event Without Identified Device or Use Problem3
- Appropriate Device Problem Term/Code Not Available2
- Bent1
- Detachment of Device or Device Component1
- Failure to Align1
- Mechanical Jam1
Patient problems
- No Consequences Or Impact To Patient6
- No Code Available3
- No Known Impact Or Consequence To Patient3
- No Patient Involvement3
- Failure of Implant2
- No Clinical Signs, Symptoms or Conditions2
- Injury1
- Insufficient Information1
DHHS models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DHHS 338.348Guide, surgical, instrument5 reports
- DHHS 338.345ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- DHHS 338.341Guide, surgical, instrument3 reports
- DHHS 282.612APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 reports
- DHHS 282.236SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- DHHS 282.240SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- DHHS 282.602APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- DHHS 282.610APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- DHHS 282.610SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- DHHS 282.611APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- DHHS 282.670SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- DHHS 282.676APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- DHHS 338.346ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
Recent DHHS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025 THAT THERE WAS AN ISSUE WITH THE LCP DHHS COUPLING SCREW. THE THREADED TIP BROKE OFF DURING A REMOVAL SURGERY IN HARDWARE REMOVAL. PATIENT WAS REVISED TO A TOTAL HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 22727956 ↗InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT UNDERWENT DYNAMIC HIP SYSTEM (DHS). THERE WAS SURGICAL SITE INFECTION POSTOPERATIVE COMPLICATIONS REPORTED. PATIENT STATUS/ OUTCOME? FRACTURE UNITED AFTER REVISION WITH ANTIBIOTIC COATED IMN. THIS REPORT IS FOR ONE (1) 135 DEG LCP DHHS SIDEPL-STD BRL 4 H THIS IS REPORT 1 OF 5 FOR COMPLAINT ((B)(4).
Patient problems: Unspecified Infection
MAUDE report 15801621 ↗InjuryDec 28, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BARREL PLATE WOULDN'T SEAT OVER BLADE AND BOTH IMPACTOR CAP TIP BROKE IN THE PROCESS. I'M NOT SURE WHICH ONE WAS AT FAULT SO I WILL GIVE YOU THE NUMBERS FOR THEM ALL. NOTHING WAS LEFT IN THE PATIENT. ENDED UP REMOVING EVERYTHING AND USING CANNULATED SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN NUMBER OF SURGICAL DELAYS. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) LCP® DHHS(TM) IMPACTOR CAP. THIS REPORT IS 5 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11079908 ↗InjuryDec 28, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BARREL PLATE WOULDN'T SEAT OVER BLADE AND BOTH IMPACTOR CAP TIP BROKE IN THE PROCESS. I'M NOT SURE WHICH ONE WAS AT FAULT SO I WILL GIVE YOU THE NUMBERS FOR THEM ALL. NOTHING WAS LEFT IN THE PATIENT. ENDED UP REMOVING EVERYTHING AND USING CANNULATED SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN NUMBER OF SURGICAL DELAYS. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) LCP® DHHS(TM) IMPACTOR CAP. THIS REPORT IS 4 OF 5 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11079898 ↗InjuryDec 28, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BARREL PLATE WOULDN¿T SEAT OVER BLADE AND BOTH IMPACTOR CAP TIP BROKE IN THE PROCESS. I¿M NOT SURE WHICH ONE WAS AT FAULT SO I WILL GIVE YOU THE NUMBERS FOR THEM ALL. NOTHING WAS LEFT IN THE PATIENT. ENDED UP REMOVING EVERYTHING AND USING CANNULATED SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN NUMBER OF SURGICAL DELAYS. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) DHHS HELIX BLADE 85MM-STERILE. THIS REPORT IS 2 OF 5 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 11079863 ↗InjuryDec 28, 2020Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE BARREL PLATE WOULDN¿T SEAT OVER BLADE AND BOTH IMPACTOR CAP TIP BROKE IN THE PROCESS. I¿M NOT SURE WHICH ONE WAS AT FAULT SO I WILL GIVE YOU THE NUMBERS FOR THEM ALL. NOTHING WAS LEFT IN THE PATIENT. ENDED UP REMOVING EVERYTHING AND USING CANNULATED SCREWS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNKNOWN NUMBER OF SURGICAL DELAYS. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR (1) 130 DEG LCP® DHHS(TM) SIDEPLATE-SHRT BARREL 2H-STER. THIS REPORT IS 1 OF 5 FOR (B)(4).
Patient problems: Failure of Implant
MAUDE report 11079856 ↗InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT REMOVAL OF DYNAMIC HELICAL HIP SYSTEM (DHHS) FOLLOWED BY CONVERSION OF TOTAL HIP REPLACEMENT. THE PATIENT WAS ORIGINALLY IMPLANTED WITH THE DHHS SYSTEM ON AN UNKNOWN DATE. THE PROCEDURE AND PATIENT OUTCOMES ARE UNKNOWN. THIS IS REPORT 2 OF 10 FOR (B)(4). THIS REPORT IS FOR A LCP SIDE PLATE. (B)(4) IS LINKED TO THIS COMPLAINT.
Patient problems: Injury
MAUDE report 10395323 ↗InjuryMay 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL WAS PERFORMED DUE TO NON-UNION AND REVISION TO TOTAL HIP REPLACEMENT. THE ORIGINAL DATE OF IMPLANT WAS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICES REPORTED HELIX BLADE 95MM (PART NUMBER 282.238, LOT NUMBER H793959 , QUANTITIES 1), SCREWS: CANNULATED (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITIES 1). THIS COMPLAINT IS FOR ONE (1) 135 DEG LCP® DHHS(TM) SIDEPLATE-STD BARREL 2 HOLES. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 10039301 ↗MalfunctionNov 26, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR USING A DYNAMIC HELICAL HIP SYSTEM (DHHS). THE HELICAL/HELIX BLADE WAS INSERTED IN A NORMAL FASHION. AS THE SURGEON WENT TO KEY IN THE HELICAL BLADE, THE HELICAL BLADE OVER-INSERTED. WHEN THE SURGEON TRIED TO BACK UP THE HELICAL BLADE, IT WOULD NOT SLIDE THROUGH THE PLATE/SIDE PLATES STANDARD BARREL. THE HELICAL BLADE AND THE PLATE WERE REMOVED IN A SINGLE PIECE AND A NEW HELICAL BLADE AND PLATE WERE REINSERTED WITHOUT INCIDENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 9377755 ↗MalfunctionNov 26, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR USING A DYNAMIC HELICAL HIP SYSTEM (DHHS). THE HELICAL/HELIX BLADE WAS INSERTED IN A NORMAL FASHION. AS THE SURGEON WENT TO KEY IN THE HELICAL BLADE, THE HELICAL BLADE OVER-INSERTED. WHEN THE SURGEON TRIED TO BACK UP THE HELICAL BLADE, IT WOULD NOT SLIDE THROUGH THE PLATE/SIDE PLATES STANDARD BARREL. THE HELICAL BLADE AND THE PLATE WERE REMOVED IN A SINGLE PIECE AND A NEW HELICAL BLADE AND PLATE WERE REINSERTED WITHOUT INCIDENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Code Available
MAUDE report 9377445 ↗MalfunctionSep 13, 2019Break; Break
IT WAS REPORTED THAT ON AUGUST 15, 2019, DURING FIELD INSPECTION THE FOLLOWING ITEMS WERE FOUND BROKEN: ONE (1) CABLE TENSIONER DEVICE HAS SOMETHING STUCK INSIDE OF IT PREVENTING PROPER USE, TOP CLIP OF THE TWO (2) LOCKING COMPRESSION PLATE DYNAMIC HELICAL HIP SYSTEM INSERTER GUIDE WERE BROKEN PREVENTING PROPER USE, ONE (1) LOCKING COMPRESSION PLATE DYNAMIC HELICAL HIP SYSTEM INSERTER SHAFT IS NOT ROUND THEREFORE SCREW CANNOT PASS THROUGH INSTRUMENT, THE HANDLE OF ONE (1) SCREWDRIVER T15 CRACKED, ONE (1) CANNULATED HEXAGONAL SCREWDRIVER SHOULD HAVE ROUND TIP THEREFORE SCREWS DOES NOT FIT, HANDLE OF THE ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE WAS BUSTED, AND THE TIP OF THE ONE (1) DEPTH GAUGE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 4 FOR 5 (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9031032 ↗MalfunctionSep 13, 2019Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2019, DURING FIELD INSPECTION THE FOLLOWING ITEMS WERE FOUND BROKEN: ONE (1) CABLE TENSIONER DEVICE HAS SOMETHING STUCK INSIDE OF IT PREVENTING PROPER USE, TOP CLIP OF THE TWO (2) LOCKING COMPRESSION PLATE DYNAMIC HELICAL HIP SYSTEM INSERTER GUIDE WERE BROKEN PREVENTING PROPER USE, ONE (1) LOCKING COMPRESSION PLATE DYNAMIC HELICAL HIP SYSTEM INSERTER SHAFT IS NOT ROUND THEREFORE SCREW CANNOT PASS THROUGH INSTRUMENT, THE HANDLE OF ONE (1) SCREWDRIVER T15 CRACKED, ONE (1) CANNULATED HEXAGONAL SCREWDRIVER SHOULD HAVE ROUND TIP THEREFORE SCREWS DOES NOT FIT, HANDLE OF THE ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE WAS BUSTED, AND THE TIP OF THE ONE (1) DEPTH GAUGE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 2 FOR 5 (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9030788 ↗MalfunctionSep 13, 2019Break; Break
IT WAS REPORTED THAT ON AUGUST 15, 2019, DURING FIELD INSPECTION THE FOLLOWING ITEMS WERE FOUND BROKEN: ONE (1) CABLE TENSIONER DEVICE HAS SOMETHING STUCK INSIDE OF IT PREVENTING PROPER USE, TOP CLIP OF THE TWO (2) LOCKING COMPRESSION PLATE DYNAMIC HELICAL HIP SYSTEM INSERTER GUIDE WERE BROKEN PREVENTING PROPER USE, ONE (1) LOCKING COMPRESSION PLATE DYNAMIC HELICAL HIP SYSTEM INSERTER SHAFT IS NOT ROUND THEREFORE SCREW CANNOT PASS THROUGH INSTRUMENT, THE HANDLE OF ONE (1) SCREWDRIVER T15 CRACKED, ONE (1) CANNULATED HEXAGONAL SCREWDRIVER SHOULD HAVE ROUND TIP THEREFORE SCREWS DOES NOT FIT, HANDLE OF THE ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE WAS BUSTED, AND THE TIP OF THE ONE (1) DEPTH GAUGE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 FOR 5 (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9030674 ↗MalfunctionMay 16, 2019Break; Break
IT WAS REPORTED THAT ON (B)(6) 2019, THE LOCKING COMPRESSION PLATE (LCP) DHHS IMPACTOR CAP WAS BROKEN DURING THE CASE. FRAGMENTS WERE GENERATED BUT EASILY REMOVED. THERE WAS NO SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR AN IMPACTOR CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8617009 ↗MalfunctionOct 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE LOCKING COMPRESSION PLATE (LCP) DYNAMIC HELICAL HIP SYSTEM (DHHS) INSERTER GUIDE IS COMING APART. ISSUE WAS DISCOVERED IN STERILE PROCESSING ON UNKNOWN DATE. NO PATIENT OR SURGICAL PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) LCP DHHS INSERTER GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Patient Involvement
MAUDE report 8008794 ↗
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