BALL NOSE GUIDE WIRE 2810-01-100Recalls & reported problems
Biomet Orthopedics, LLC · Class 1
All models of BALL NOSE GUIDE WIRE (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00887868027864), received between Dec 27, 2019 and Oct 10, 2023 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 reports).
1 FDA recall record name this device's identifier.
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 18, 2026.
Reports received per month
Recalls naming this device
- Aug 21, 2019Class IITerminated
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Z-0530-2020 · Root cause: Environmental control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture2
- Tear, Rip or Hole in Device Packaging1
Patient problems
- Foreign Body In Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 17904490 ↗InjuryMar 7, 2023Fracture; Fracture
IT WAS FURTHER REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY APPROXIMATELY 2 MONTHS AGO. SUBSEQUENTLY, DURING THE PROCEDURE THE FEMORAL SHAFT WAS FOUND TO BE VERY DENSE, AND IT WAS DECIDED TO PERFORM MOTORIZED REAMING. DURING THE REAMING, THE GUIDE PIN FRACTURED LEAVING PART OF THE PIN IN THE FEMORAL SHAFT. THE SURGERY COULD NOT BE COMPLETED DUE TO A LACK OF NECESSARY EQUIPMENT AS THE SURGEON NOW NEEDED TO COMPLETE A FEMOROTOMY AND IMPLANT A LONG REVISION STEM. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE THE SURGERY WAS COMPLETED A DAY LATER.
Patient problems: Foreign Body In Patient
MAUDE report 16499635 ↗MalfunctionDec 27, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THERE IS A HOLE IN INTERNAL AND EXTERNAL PACKAGING. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9523129 ↗
Other Guide, surgical, instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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