MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GENDER SOLUTIONS PATELLO-FEMORAL JOINT (PFJ) MILLING BURR STANDARD; INSTRUMENT, SURGICAL, ORTHOPEDIC

Catalog Number	00592705000
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: medical product: milling handpiece: catalog# 00592704000, serial# (b)(6).The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the milling burr component of the handpiece instrument was found to be bent and was unable to be removed from the milling handpiece after surgery.There were no issues with the device during the procedure and no patient impact was reported as a result of the malfunction.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
H6: proposed component code: mechanical (g04) - drill.Visual examination of the returned products identified the burr is seized in the handpiece and the two devices are unable to disassembled.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Complaint sample was evaluated and the reported event was confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: GENDER SOLUTIONS PATELLO-FEMORAL JOINT (PFJ) MILLING BURR STANDARD
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20171480
• Report Number: 0001822565-2024-02900
• Device Sequence Number: 8249851
• Product Code: HWE
• UDI-Device Identifier: 00889024206144
• UDI-Public: (01)00889024206144(17)290128(10)66188577
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: Health Professional
• Device Catalogue Number: 00592705000
• Device Lot Number: 66188577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose