NexGen® 00-5901-021-00Recalls & reported problems
Zimmer, Inc. · Class 1
Quick summary
This Zimmer NexGen extractor is a surgical instrument used to place pins and screws during bone fixation surgery. The 28 adverse event reports mostly describe the tool breaking or fracturing mid-procedure — sometimes with small pieces falling into the patient, though in the reported cases the pieces were retrieved and no harm followed. There are no deaths and no injuries. No recalls name this device, and no reports were filed in the past 12 months.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00889024201637), received between Sep 10, 2019 and May 13, 2024 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Fracture” (26 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
- Fracture26
- Mechanical Jam2
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE PIN/SCREW INSERTER BROKE WHEN TRYING TO PUT A SCREW DURING THE SURGERY. SURGICAL TECHNIQUE WAS FOLLOWED AND NO PARTS OF THE INSTRUMENT WENT INTO THE PATIENT. NO HARM TO THE PATIENT OCCURRED AND IT IS UNKNOWN HOW MANY TIMES THE DEVICE WAS USED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19304108 ↗MalfunctionNov 13, 2023Fracture; Fracture
IT WAS REPORTED THAT A DRIVER FRACTURED DURING SURGERY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18124457 ↗MalfunctionSep 11, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17722524 ↗MalfunctionJun 13, 2023Fracture; Fracture
IT WAS REPORTED THAT A DRILL PIN AND SCREW INSERTER FRACTURED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17118908 ↗MalfunctionMay 8, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16886066 ↗MalfunctionMay 3, 2023Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16860296 ↗MalfunctionApr 20, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16782389 ↗MalfunctionApr 20, 2023Fracture; Fracture
IT WAS REPORTED THE PIN/SCREW INSERTER BROKE WHILE SURGEON WAS INSERTING SCREWS INTO SIZER. SOME FRACTURED PIECES FELL INTO THE PATIENT. ALL PIECES WERE RETRIEVED. NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16775742 ↗MalfunctionMar 2, 2023Fracture; Fracture
IT WAS REPORTED THAT THE PIN AND SCREW INSERTER FRACTURED WHILE DRIVING SCREW INTO FEMUR THROUGH A/P SIZER. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16466199 ↗MalfunctionFeb 9, 2023Fracture; Fracture
IT WAS REPORTED THAT THE TRIAL WAS FOUND BROKEN WHEN ASSEMBLING THE TRAY. IT WAS NOT USED IN THE PROCEDURE. NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16336498 ↗MalfunctionJan 19, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16205103 ↗MalfunctionJan 9, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16122293 ↗MalfunctionDec 14, 2022Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15980774 ↗MalfunctionOct 6, 2022Fracture; Fracture
IT WAS REPORTED THAT THE TROCAR DRIVER TIP WAS BROKEN. THE EVENT OCCURRED OUTSIDE THE OPERATING ROOM. THERE WAS NO IMPACT ON THE PATIENT OR PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15551132 ↗MalfunctionJun 27, 2022Fracture; Fracture
IT WAS REPORTED THAT A HEX PIN DRIVER FRACTURED DURING SCREW INSERTION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14829947 ↗MalfunctionMay 13, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL KNEE PROCEDURE, A SCREW DRIVER FRACTURED DURING SCREW INSERTION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION. THE SURGERY WAS COMPLETED WITH A SECOND INSTRUMENT WITHOUT COMPLICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14395259 ↗MalfunctionApr 26, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING AN INITIAL KNEE PROCEDURE, A SCREWDRIVER FRACTURED. THE BROKEN PIECE WAS RETRIEVED AND THE SURGERY WAS COMPLETED WITH A SECOND DEVICE WITHOUT COMPLICATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14208886 ↗MalfunctionApr 19, 2022Fracture; Fracture
IT WAS REPORTED THE TIP OF THE PIN DRIVER BROKE OFF WHEN INSERTING A SCREW. THE BROKEN PIECE WAS LOCATED AND ANOTHER WAS AVAILABLE. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14140726 ↗MalfunctionApr 14, 2022Fracture; Fracture
IT WAS REPORTED THAT WHILE USING THE 3.2X75 PERSONA PINS, THE TIP BROKE OFF INTO PART 00-5901-021-00. THE FRACTURED PIECE STAYED IN THE INSERTER. NO PATIENT IMPACT. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14111560 ↗MalfunctionDec 3, 2021Mechanical Jam; Mechanical Jam
IT WAS REPORTED THE PINS BLOCKED THE BOREHOLE DAMAGING THE PIN DRIVER. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12923168 ↗MalfunctionNov 30, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12891104 ↗MalfunctionOct 27, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12707394 ↗MalfunctionJul 12, 2021Fracture; Fracture
NO ADDITIONAL INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12151219 ↗MalfunctionMay 6, 2021Fracture; Fracture
IT WAS REPORTED THAT DURING A PERSONA KNEE REVISION, THE PIN DRIVER BROKE WHEN PUTTING IN A 3.5 X 27MM HEX SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11782572 ↗MalfunctionFeb 17, 2021Mechanical Jam
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11337227 ↗
Other EXTRACTOR devices
- ATTUNE 2545-00-138Depuy (Ireland) · EXTRACTOR392 reports
- PINNACLE 2217-50-001Depuy (Ireland) · EXTRACTOR243 reports
- RECLAIM 2975-00-635Depuy (Ireland) · EXTRACTOR157 reports
- ATTUNE 2545-00-060Depuy (Ireland) · EXTRACTOR153 reports
- ESC PINNACLE 2218-00-010Depuy (Ireland) · EXTRACTOR151 reports
- NA 2125-00-600Depuy Orthopaedics, Inc. · EXTRACTOR130 reports
- P.F.C. 86-5226Depuy (Ireland) · EXTRACTOR80 reports
- NA 03.010.000Synthes GmbH · EXTRACTOR74 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.