MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PROVISIONAL SHELL IMPACTOR HANDLE; INSTRUMENT, HIP

Catalog Number	00705003400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: canada.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 tip of black handle cup impactor has broken off into the threaded hole of the 62/64 pie impactor.There is no further information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, d4: lot, d9, g3, g6, h2, h11.
Event or Problem Description
There is no update to the prior event description provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4;d4;g3;h2;h3;h4;h6.Product was returned and evaluated.Visual examination of the returned product identified that the threaded end of the driver weldment was fractured; no fractured segments were returned with device.The device showed signs of use with scratches on the driver weldment shaft and guide holder.The strike plate and guide holder also had indentations.No other damage was noted during visual evaluation.Review of the device history records identified no deviations or anomalies during manufacturing.Reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.A definitive root cause cannot be determined.The complaint was confirmed based on the returned, fractured device.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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.Upon an internal data review, it was determined that this device was reported under the incorrect manufacturer.This report should be considered void, and the event will be reported under mfr 3005751028.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon an internal data review, it was determined that this device was reported under the incorrect manufacturer.This report should be considered void, and the event will be reported under mfr 3005751028.

• Brand Name: PROVISIONAL SHELL IMPACTOR HANDLE
• Common Device Name: INSTRUMENT, HIP
• 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: 21576721
• Report Number: 0001822565-2025-00582
• Device Sequence Number: 8271844
• Product Code: HWE
• UDI-Device Identifier: 00889024311411
• UDI-Public: (01)00889024311411(11)210521(10)64996482
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,Followup
• Report Date (Section B): 04/22/2026

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: Health Professional
• Device Catalogue Number: 00705003400
• Device Lot Number: 64996482
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 06/19/2025; 04/22/2026
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/07/2025; 06/25/2025; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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