SPECIALIST 96-6520Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 UNIVERSAL HANDLE · Class 1
All models of SPECIALIST (80)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Specialist 2 universal handle is a hand-held surgical instrument used to seat implants during joint replacement. Many of its 190 reports describe the handle breaking, often at its connection point during impaction. A report describes a nurse hurt by a flying piece during surgery. There is 1 injury report and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 190
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 190 adverse event reports that list this exact device (DI 10603295248644), received between Jul 11, 2017 and Jun 17, 2026 — classified as 1 injury, 189 malfunctions.
The most frequently reported specific device problem is “Break” (167 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break167
- Device-Device Incompatibility23
- Material Integrity Problem5
- Naturally Worn5
- Adverse Event Without Identified Device or Use Problem4
- Crack3
- Material Deformation3
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions84
- No Consequences Or Impact To Patient79
- No Information17
- Insufficient Information12
- No Code Available2
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 190 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Break
IT WAS REPORTED THAT THE TIBIAL CEMENTLESS IMPACTOR BROKE AT THE CONNECTION PART WHEN BEING MALLETED IN CASE. IT WAS UNKNOWN IF THERE WAS A DELAY DUE TO THE REPORTED EVENT. IT WAS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS UNKNOWN IF FRAGMENTS WERE GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538099 ↗MalfunctionSep 5, 2025Break; Break
IT WAS REPORTED THE UNIVERSAL HANDLE BROKE DURING IMPACTION; ALL PIECES WERE RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22977518 ↗InjuryJun 26, 2025Break; Break
IT WAS REPORTED DURING A KNEE SURGERY, A FLYING PARTICLE OF THE FEMORAL IMPACTOR HAS INJURED THE NURSE IN HER CHEST. NO SURGICAL DELAY. THE NURSE HAD A RIGHT-SIDED THORACAL PUNCTURED WOUND FOREIGN BODY. THE PATIENT HAD FLUSHING OF THE WOUND AND BANDAGE APPLIED AND A TETANUS VACCINE WAS GIVEN. THE TORN PART IS STILL INSIDE THE INJURED NURSE'S BODY, AS ITS SURGERY IS COMPLICATED, AND IT MAY REMAIN THERE.
Patient problems: Unspecified Tissue Injury
MAUDE report 22336323 ↗MalfunctionApr 30, 2025Break; Break
IT WAS REPORTED THAT WHEN THE DOCTOR WAS IMPACTING THE DEFINITIVE FEMUR FALLS THE TOP OF THE UNIVERSAL HANDLE.
Patient problems: Insufficient Information
MAUDE report 21936254 ↗MalfunctionOct 30, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE SP2 UNIVERSAL HANDLE BROKE AND WOULD NOT CONNECT TO ANY ATTACHMENT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20565957 ↗MalfunctionOct 30, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE SP2 UNIVERSAL HANDLE BROKE AND WOULD NOT CONNECT TO ANY ATTACHMENT. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 20565923 ↗MalfunctionOct 28, 2024Break; Break
IT WAS REPORTED THAT SIGMA FEMORAL IMPACTOR HANDLE ATTACHMENT RING BROKE OFF DURING IMPACTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20544198 ↗MalfunctionOct 11, 2024Break; Break
IT WAS REPORTED DURING INSPECTION OF THE ORTHOKIT, IT WAS NOTED THE UNIVERSAL HANDLE WAS BROKEN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20427274 ↗MalfunctionOct 9, 2024Break; Break
IT WAS REPORTED THAT THE SIGMA TIBIAL BLOCK BROKE AND SIGMA UNIVERSAL HANDLE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20412897 ↗MalfunctionOct 9, 2024Break; Break
IT WAS REPORTED THAT THE SIGMA TIBIAL BLOCK BROKE AND THE SIGMA UNIVERSAL HANDLE BROKE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20412880 ↗MalfunctionOct 9, 2024Break; Break
IT WAS REPORTED THAT THE SIGMA TIBIAL BLOCK BROKE AND THE SIGMA UNIVERSAL HANDLE BROKE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20412642 ↗MalfunctionOct 9, 2024Break; Break
IT WAS REPORTED THAT THE SIGMA TIBIAL BLOCK BROKE AND SIGMA UNIVERSAL HANDLE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20412520 ↗MalfunctionOct 7, 2024Break; Break
IT WAS REPORTED THAT DURING SURGERY, THE FEMORAL AND TIBIAL FIXATION PINS WERE VERY TWISTED AND THE SURGEON HAD TO WORK WITH THEM IN THAT STATE. IN ADDITION TO THIS, ONE OF THE IMPACTOR HANDLES WAS DISASSEMBLED. THE FRAGMENTS WERE REMOVED AND THE OTHER IMPACTOR HANDLE THAT COMES WITH THE EQUIPMENT WAS USED TO GIVE A PROMPT SOLUTION TO THIS NOVELTY TO THE SURGEON, BUT EVEN SO ALL THIS GENERATED DISCOMFORT IN THE SPECIALIST; HOWEVER, THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20383119 ↗MalfunctionSep 10, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
IT WAS REPORTED THAT THE ITEM IS DAMAGED, WILL NOT CONNECT TO IMPACTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20180874 ↗MalfunctionSep 4, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT THE ISSUE WAS PICKED UP AT THE START OF THE CASE SO THERE WAS NO SURGERY TIME AND NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20139748 ↗MalfunctionSep 4, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT THE ISSUE WAS PICKED UP AT THE START OF THE CASE SO THERE WAS NO SURGERY TIME AND NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20139644 ↗MalfunctionSep 4, 2024Device-Device Incompatibility; Material Integrity Problem; Device-Device Incompatibility; Material Integrity Problem
ADDITIONAL INFORMATION RECEIVED STATES THAT THE ISSUE WAS PICKED UP AT THE START OF THE CASE SO THERE WAS NO SURGERY TIME AND NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20139632 ↗MalfunctionAug 22, 2024Break; Break
IT WAS REPORTED THAT THE HANDLE IS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20034912 ↗MalfunctionAug 22, 2024Break; Break
IT WAS REPORTED THAT THE HANDLE IS BROKEN. IT DID NOT HAPPEN IN SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20027084 ↗MalfunctionAug 8, 2024Break; Break
IT WAS REPORTED THAT THE UNIVERSAL HANDLE TIP BROKE OFF. UNKNOWN SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 19937308 ↗MalfunctionJul 25, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility
IT WAS REPORTED THAT THE UNIVERSAL HANDLE WOULD NOT CONNECT TO THE IMPACTION ATTACHMENTS DUE TO CHIPPED METAL AT THE TIP OF THE UNIVERSAL HANDLE. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19830811 ↗MalfunctionJun 19, 2024Break; Break
IT WAS REPORTED THAT THE INSTRUMENT TIP WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19568240 ↗MalfunctionJun 18, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS ARE DAMAGED AND ARE NO LONGER CONNECTING. LOT NUMBER NOT AVAILABLE HAPPENED PRE OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19564166 ↗MalfunctionJun 18, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE ITEMS ARE DAMAGED AND ARE NO LONGER CONNECTING. LOT NUMBER NOT AVAILABLE HAPPENED PRE OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19564165 ↗MalfunctionJan 18, 2024Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT THE SURGERY VIA TKA FOR THE RIGHT KNEE JOINT WITH THE HANDLE IN QUESTION. TO PLACE THE FEMORAL COMPONENT, THE HANDLE IN QUESTION WAS CONNECTED TO THE FEMORAL IMPACTOR AND STRUCK. HOWEVER, THE TIP OF THE HANDLE IN QUESTION WAS DAMAGED DURING THE PROCESS. SINCE IT COULD NOT BE CONNECTED TO THE FEMORAL IMPACTOR, ANOTHER DEVICE WAS SUBSTITUTED. IT WAS THOUGHT THAT DETERIORATION OVER TIME WAS THE CAUSE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18539987 ↗
Other ORTHOPEDIC MANUAL SURGICAL INSTRUMENT devices
- AML EXCEL 2001-42-000Depuy (Ireland) · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2,009 reports
- NA 03.010.523Synthes GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,208 reports
- EXPRESSEW 214141Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,166 reports
- N/A 9560524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT866 reports
- INHANCE 6500-11-104Depuy (Ireland) · Orthopedic manual surgical instrument831 reports
- INHANCE 6500-11-102Depuy (Ireland) · Orthopedic manual surgical instrument567 reports
- R3 71364450Smith & Nephew, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT520 reports
- N/A 9561524Medtronic Sofamor Danek, Inc. · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT494 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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