SUMMITRecalls & reported problems across all models
Depuy (Ireland) · 43 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,320
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 43 models of SUMMIT by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 1,320 adverse event reports in the FDA's MAUDE database, received between Jul 7, 2017 and Sep 15, 2026 — classified as 10 injuries, 1,310 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (355 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 SUMMIT problems
Device problems
- Device-Device Incompatibility355
- Failure to Cut250
- Break249
- Naturally Worn169
- Material Twisted/Bent159
- Dull, Blunt158
- Material Deformation90
- Unintended Movement81
Patient problems
- No Clinical Signs, Symptoms or Conditions678
- No Consequences Or Impact To Patient497
- Insufficient Information89
- No Information31
- No Code Available26
- Not Applicable24
- Limb Fracture5
- Bone Fracture(s)1
SUMMIT models
43 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SUMMIT 2570-00-000BROACH269 reports
- SUMMIT 2570-05-100DRIVER, PROSTHESIS225 reports
- SUMMIT 2570-04-100Bone mill193 reports
- SUMMIT 2570-05-250HAMMER, SURGICAL100 reports
- SUMMIT 2570-04-200Bone mill91 reports
- SUMMIT 2570-02-300REAMER48 reports
- SUMMIT 2570-02-200REAMER31 reports
- SUMMIT 2570-00-005REAMER30 reports
- SUMMIT 2570-02-100REAMER28 reports
- SUMMIT 2570-10-000TRAY, SURGICAL, INSTRUMENT25 reports
- SUMMIT 2570-02-400REAMER23 reports
- SUMMIT 2570-00-120BROACH22 reports
- SUMMIT 2570-00-135BROACH22 reports
- SUMMIT 2570-00-002BROACH18 reports
- SUMMIT 2570-00-100BROACH17 reports
- SUMMIT 2570-02-000REAMER17 reports
- SUMMIT 2570-00-110BROACH16 reports
- SUMMIT 2570-03-200ORTHOPEDIC MANUAL SURGICAL INSTRUMENT13 reports
- SUMMIT 2570-03-250ORTHOPEDIC MANUAL SURGICAL INSTRUMENT12 reports
- SUMMIT 2570-03-050ORTHOPEDIC MANUAL SURGICAL INSTRUMENT11 reports
- SUMMIT 2570-03-100ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- SUMMIT 2570-03-150ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- SUMMIT 2570-03-300ORTHOPEDIC MANUAL SURGICAL INSTRUMENT9 reports
- SUMMIT 2570-00-150BROACH8 reports
- SUMMIT 2570-03-350ORTHOPEDIC MANUAL SURGICAL INSTRUMENT8 reports
- SUMMIT 2570-00-090BROACH7 reports
- SUMMIT 2570-02-500REAMER7 reports
- SUMMIT 2570-00-080BROACH5 reports
- SUMMIT 2570-00-165BROACH5 reports
- SUMMIT 2570-03-400ORTHOPEDIC MANUAL SURGICAL INSTRUMENT5 reports
- SUMMIT 2570-00-070BROACH4 reports
- SUMMIT 2570-03-000ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- SUMMIT 2570-00-060BROACH3 reports
- SUMMIT 2570-00-180BROACH3 reports
- SUMMIT 2570-03-450ORTHOPEDIC MANUAL SURGICAL INSTRUMENT3 reports
- SUMMIT 2570-20-000GAUGE, DEPTH3 reports
- SUMMIT 2570-21-000GAUGE, DEPTH3 reports
- SUMMIT 2570-22-000GAUGE, DEPTH3 reports
- SUMMIT 2570-23-000GAUGE, DEPTH3 reports
- SUMMIT 2570-24-000GAUGE, DEPTH3 reports
- SUMMIT 2570-03-500ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- SUMMIT 2570-03-550ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- SUMMIT 2570-01-600TEMPLATE1 report
Recent SUMMIT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779052 ↗MalfunctionSep 10, 2026Device-Device Incompatibility
It was reported that broach handle would not lock.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717877 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50227829 ↗MalfunctionJul 9, 2026Device-Device Incompatibility; Unintended Movement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25765288 ↗MalfunctionMay 8, 2026Break; Crack; Peeled/Delaminated
IT WAS REPORTED THAT THE METAL IS DELAMINATING FROM PLASTIC, THE PLASTIC LIDS ARE BROKEN. THE PLASTIC IS CRACKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25122711 ↗MalfunctionMay 4, 2026Material Deformation
IT WAS REPORTED THAT THE T-HANDLES HAVE A LARGE CRACK IN THE MIDDLE AND CANNOT BE STERILIZED. THE SUMMIT STANDARD STEM INSERTER HAS A DEFORMED TIP AND CANNOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25067590 ↗MalfunctionApr 23, 2026Break
IT WAS REPORTED THAT THE SLAP HAMMER END WAS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24972003 ↗MalfunctionApr 15, 2026Break
IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE STRIKE PLATE WAS BROKEN OFF BROACH HANDLE, THE REAMER HANDLE WOULD NOT FIT IN THE CHUCK, AND IT WAS VERY HARD TO DISASSEMBLE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24889544 ↗MalfunctionApr 9, 2026Break
IT WAS REPORTED THAT THE SUMMIT UNIVERSAL BROACH HANDLE HAD A BROKEN LOCKING MECHANISM ON A CONSIGNMENT C STEM BROACH HANDLE. THE EVENT OCCURRED PRE-OPERATIVELY, AND A REPLACEMENT WAS REQUESTED. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829878 ↗MalfunctionMar 4, 2026Break
IT WAS REPORTED THAT SLAP HAMMER BROKE OFF INSIDE CUP INSERTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505457 ↗MalfunctionMar 4, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS PEELING WOULD NOT STERILIZE. THE EVENT DID NOT HAPPEN IN SURGERY. (B)(4) IS RELATED TO (B)(4). (B)(4) IS CREATED TO CAPTURE ADDITIONAL IPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24505222 ↗MalfunctionMar 4, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE TRAYS PEELING WOULD NOT STERILIZE. THE EVENT DID NOT HAPPEN IN SURGERY. (B)(4) IS RELATED TO (B)(4) IS CREATED TO CAPTURE ADDITIONAL IPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24504909 ↗MalfunctionFeb 27, 2026No Apparent Adverse Event
IT WAS REPORTED THAT THE TRAY INSERT WAS CRACKED AND SPD ASKED FOR IT TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24472783 ↗MalfunctionFeb 20, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THE INSTRUMENT HAS A BLUNTED TIP; GETS STUCK INSIDE STEM AND MUST BE FORCIBLY REMOVED. NO PATIENT OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400385 ↗MalfunctionFeb 4, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE A SHARD OF METAL HAS BROKEN OFF FROM ONE OF THE CUTTING EDGES OF THE PLANER. SURGEON HAD FINISHED USING IT. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24261383 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) 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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