MAUDE Adverse Event Report: ZIMMER GMBH FLEXIBLE SHAFT, TRI-SHANK; TRAUMA, DRILL SHAFT.

Catalog Number	00879000705
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: item # 00879000705, flexible shaft, tri-shank, lot # unknown.G2: report source japan.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that two drill shafts were broken during the procedure, an identical instrument was used to complete the procedure.There was no impact on the patient and all debris were recovered.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).One instrument was returned for investigation (the other was discarded at the hospital as per correspondence) the event of fracture for the returned instrument can be confirmed as the tri-shank is fractured in the spring-shaped part.Some cracks were detected on the flat surface of the spring area, radiating from the inside hole towards the outside.A review of the device manufacturing records confirmed no abnormalities or deviations for the item with known lot number.Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination for the item with known lot number.However, due to the lack of the lot number for the other item, an additional lot search could not be performed.Based on the available information, the reported event can be confirmed for one of the instrument (the returned one) and not for the other.With the available information, a definitive root cause cannot be established.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 available at the time of this report.

• Brand Name: FLEXIBLE SHAFT, TRI-SHANK
• Common Device Name: TRAUMA, DRILL SHAFT.
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21738813
• Report Number: 0009613350-2025-00206
• Device Sequence Number: 4109039
• Product Code: HWE
• UDI-Device Identifier: 00889024277014
• UDI-Public: (01)00889024277014(10)4504477576
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: 00879000705
• Device Lot Number: 4504477576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/06/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE
• Patient Sex: Unknown