SPECIALIST 96-6505Recalls & reported problems
Depuy (Ireland) · SPECIALIST 2 STEINMAN PIN INSERTER · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Specialist 2 Steinman pin inserter is a surgical instrument used to place pins during hip replacement surgery. The 30 reports mostly describe the tool jamming or seizing so it won't release from other instruments, pin holders that no longer grip the pin and let it fall out, a gasket that stopped working, and instruments cracking during a case. No deaths or injuries are reported, and 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10603295248613), received between Aug 22, 2018 and Sep 27, 2024 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (20 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device-Device Incompatibility20
- Detachment of Device or Device Component3
- Naturally Worn3
- Break2
- Appropriate Device Problem Term/Code Not Available1
- Mechanical Jam1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- No Consequences Or Impact To Patient5
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE DEVICE COULDN'T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. AS A RESULT, THIS COMPLAINT WAS CREATED TO ANALYZE THE RETURNED DEVICE. DURING THE PRELIMINARY ANALYSIS OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT DEVICE IS JAMMED/SEIZED AND IS UNABLE TO DISENGAGE FROM MATING DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20323407 ↗MalfunctionAug 9, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN HOLDER WILL NO LONGER HOLD PIN. THE EVENT DID NOT HAPPEN DURING A SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950497 ↗MalfunctionJan 17, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE FEMORAL IMPACTOR CRACKED AND THE PIN HOLDER WOULD NOT HOLD A PIN. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE
Patient problems: Insufficient Information
MAUDE report 18524759 ↗MalfunctionJul 31, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN HOLDERS ARE NO LONGER HOLDING ON TO THE PIN. THE PINS FALL RIGHT OUT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17424460 ↗MalfunctionJul 31, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN HOLDERS ARE NO LONGER HOLDING ON TO THE PIN. THE PINS FALL RIGHT OUT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17424412 ↗MalfunctionJul 21, 2023Mechanical Jam; Mechanical Jam
IT WAS REPORTED THAT THE GASKET DID NOT WORK INSIDE THE INSERTER.
Patient problems: Insufficient Information
MAUDE report 17369879 ↗MalfunctionMay 16, 2023Break; Break
IT WAS REPORTED THAT THE INSTRUMENTS BROKE DURING CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16939426 ↗MalfunctionApr 4, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THE PIN HOLDER WAS NOT HOLDING THE PINS CORRECTLY ANYMORE. ITEM MALFUNCTIONED DURING PROCEDURE. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16674853 ↗MalfunctionJan 13, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN HOLDER WILL NO LONGER HOLD THE PIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16158866 ↗MalfunctionAug 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE PIN PUSHER WAS MISSING AT THE START OF THE CASE. THE RUBBER STOPPER THAT KEEP THE TIB PIN HELD SECURELY IS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15293929 ↗MalfunctionAug 12, 2022Device-Device Incompatibility; Naturally Worn; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THE PIN HOLDER NO LONGER HOLDS THE PINS PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15216841 ↗MalfunctionJun 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A WASHER IS MISSING FROM THE INSERTER. NO PATIENT IMPACT, DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14840759 ↗MalfunctionJun 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14829178 ↗MalfunctionJun 16, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS NOTED DURING A KIT INSPECTION ON THAT THE INSTRUMENT WOULD NO LONGER HOLD THE PINS AND REQUIRES REPLACEMENT. NO SURGICAL DELAY. NO ADVERSE AFFECTS ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14722380 ↗MalfunctionJun 3, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT PIN PUSHER WAS NOT HOLDING PINS. NO PIECES. THERE IS NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14597228 ↗MalfunctionJun 2, 2022Break; Break
IT WAS REPORTED THAT THE PIN INTRODUCER TIP IS BROKEN, NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14582055 ↗MalfunctionMay 16, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TWO PIN PUSHERS DO NOT GRIP PINS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14408161 ↗MalfunctionMay 16, 2022Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE TWO PIN PUSHERS DO NOT GRIP PINS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14408114 ↗MalfunctionOct 1, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PIN PUSHER STRIPPED. WON'T HOLD PINS ANYMORE. NO PIECES. IT WAS DISCARDED BY OPERATING ROOM . NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12565214 ↗MalfunctionOct 1, 2021Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PIN PUSHER STRIPPED. WON'T HOLD PINS ANYMORE. NO PIECES. IT WAS DISCARDED BY OPERATING ROOM. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12565193 ↗MalfunctionJul 29, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE O RING IN THE HANDLE WILL NO LONGER HOLD THE PIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12246282 ↗MalfunctionJun 22, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE SP2 STEINMANN PIN INSERTER WILL NOT HOLD PINS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12045892 ↗MalfunctionJun 18, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN HOLDER WILL NOT HOLD A PIN. IT FALLS OUT. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12025399 ↗MalfunctionMar 16, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN HOLDERS WEREN¿T ADEQUATELY HOLDING THE PINS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11497322 ↗MalfunctionMar 16, 2021Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PIN HOLDERS WEREN¿T ADEQUATELY HOLDING THE PINS. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11497320 ↗
Other DRIVER, PROSTHESIS devices
- ATTUNE 2544-01-005Depuy (Ireland) · DRIVER, PROSTHESIS1,383 reports
- EXPEDIUM VERSE 299704230Medos International Sàrl · DRIVER, PROSTHESIS875 reports
- NA 9200-10-029Depuy (Ireland) · DRIVER, PROSTHESIS745 reports
- MOSS 279712600Depuy Spine, LLC · DRIVER, PROSTHESIS706 reports
- NA 2598-07-440Depuy (Ireland) · DRIVER, PROSTHESIS665 reports
- NA 2598-07-570Depuy (Ireland) · DRIVER, PROSTHESIS505 reports
- VIPER 286745550Depuy Spine, LLC · DRIVER, PROSTHESIS263 reports
- SUMMIT 2570-05-100Depuy (Ireland) · DRIVER, PROSTHESIS225 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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