MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE IM REAMER 6.0MM DIA; ORTHOPAEDIC PROSTHESIS IMPLANTATION POSITIONING INSTRUMENT, REUSABLE

Catalog Number	00222800600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: taiwan.H6: proposed code: mechanical (g04)- drill.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the end of the reamer disassembled during a procedure.There was no reported patient harm.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h2, h3, h6, h11.Visual examination of the returned product confirmed the gold reamer tip has become disassembled from the body.Dimensional analysis of the inner diameter of the tip and outer diameter of the shaft were performed and found conforming to print specifications.The device shows signs of repeated use and wear.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FLEXIBLE IM REAMER 6.0MM DIA
• Common Device Name: ORTHOPAEDIC PROSTHESIS IMPLANTATION POSITIONING INSTRUMENT, REUSABLE
• 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: 22293703
• Report Number: 0001822565-2025-02033
• Device Sequence Number: 8467512
• Product Code: HWE
• UDI-Device Identifier: 00889024038738
• UDI-Public: (01)00889024038738(10)65304441
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: 00222800600
• Device Lot Number: 65304441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown