MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL WIREDRIVER MIC-MTRC 1-4MM; SURGICAL POWER TOOL

Catalog Number	89-8509-451-41
Medical Device Problem Codes	Difficult to Insert (1316); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire driver pin cannot be connected, inserted, or held in place.No consequences or impact to the patient.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2 ¿ foreign ¿ india.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d4, d9, e1, g3, g6, h1, h2, h3, h6, h11.The following section was corrected: h6 - component codes.No product was returned or pictures provided; visual and functional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Review of complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and serial combination.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.A definitive root cause cannot be determined.The event cannot be 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: UNIVERSAL WIREDRIVER MIC-MTRC 1-4MM
• Common Device Name: SURGICAL POWER TOOL
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; 1228 plan-les-ouates; geneva CH-12 28; SZ CH-1228
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 22112840
• Report Number: 0008031000-2025-00069
• Device Sequence Number: 7063119
• Product Code: HAB
• UDI-Device Identifier: 00889024354951
• UDI-Public: (01)00889024354951(11)230427(10)5018561
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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
• Device Catalogue Number: 89-8509-451-41
• Device Lot Number: 5018561
• Was Device Available for Evaluation?: No
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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