MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE DRILL TALAR PEG 4MM; BIT, SURGICAL

Catalog Number	IB200020
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "this case was missing the talar peg drill (ib200020) this caused some issues as we needed to source another 4mm drill that we could use to drill the peg holes.The drill we used came from another set and didn¿t quite fit causing heat build up on inspection after the case i noticed heat stress marks on the adaptis talar trial, and the drill bit had been rendered blunt.There was no metal debris left in the patient.This issue caused a small delay but needed extra impaction of the talus component as the drill probably didn¿t do as good a job as the real device.This patient had a 3 tibia and a 3 talus.If we had opened the previous set, we would have had some issues with the missing poly it was more luck than judgement.I normally get a no stock for these items but on this occasion, i had no email warning of the state of the sets.The sets are due to be picked up today can they be quarantined and rectified before redeployment.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.

• Brand Name: INBONE DRILL TALAR PEG 4MM
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24907199
• Report Number: 3010667733-2026-00346
• Device Sequence Number: 9085633
• Product Code: GFG
• UDI-Device Identifier: 00889797059152
• UDI-Public: 00889797059152
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: IB200020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 06/14/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown