MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR 3-IN-1 IMPACTOR; ORTHOPAEDIC IMPLANT IMPACTOR, REUSABLE

Catalog Number	110028055
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D4: attempts have been made to gather all product identification information and no further information has been provided.G2: 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 the impactor was fractured during a procedure.No broken pieces fell into the patient¿s surgical area.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, g3, g6, h2, h6, h11 d4: attempts have been made to gather all product identification information and no further information has been provided.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.It was reported that the grey tip broke, however the tip provided for this impactor is black.Per product design, the pad is attached to the handle with medical grade epoxy and is not designed to be removed as it is approved for effective cleaning and sterilization in its assembled form.Per ifu, ¿the majority of surgical instruments and trial prostheses instruments are constructed in such a way that they will not require disassembly.¿ however, it is unknown if this contributed to the reported event.A definitive root cause cannot be determined.The reported event is not confirmed for fracture.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
No further event information is 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: b4, b5, d4, d9, g3, g6, h2, h4, h11.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, d4, g3, g6, h2, h3, h6, h11 the reported event is confirmed by product return.Visual examination of the returned product identified signs of use and wear, scuffing on the handle, strike plate wear marks, no epoxy residue on the threads, the impactor tip (designated black ppsu) was not returned with the device, and the handle dimensions were conforming to the print.The device history record review.Identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.
Event or Problem Description
Attempts have been made and no further information has been provided.

• Brand Name: COMPR 3-IN-1 IMPACTOR
• Common Device Name: ORTHOPAEDIC IMPLANT IMPACTOR, REUSABLE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21903327
• Report Number: 0001825034-2025-01208
• Device Sequence Number: 8623439
• Product Code: PHX
• UDI-Device Identifier: 00887868469978
• UDI-Public: (01)00887868469978(11)230816(10)65723363
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 02/19/2026

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: 110028055
• Device Lot Number: 65723363
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 08/08/2025; 09/02/2025; 02/18/2026
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 08/15/2025; 09/22/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown