MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMPR 3-IN-1 IMPACTOR; EXTREMITY INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.
Event or Problem Description
It was reported that the impactor fractured during surgery.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the impactor shows signs of previous use.The handle of the device has some scratches and gouges.The strike plate is also gouged and the black impactor tip is fractured.There is epoxy residue on the inside threads of the black poly impactor tip.Product information verified from etch.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The root cause of the reported issue is attributed to use error.Per the comprehensive reverse shoulder system surgical technique, impactor part 110028055 should be used to impact the comprehensive humeral bearing into the comprehensive humeral tray.Per the associated ifu, ¿where used uniquely for a particular implant system, consult that system¿s labeling for the detailed indications, contraindications, performance characteristics, and expected clinical benefit for the devices.¿ while it's unknown which implant was being impacted while this device fractured, the reported impactor is not compatible with any of the comprehensive reverse shoulder implants or tm reverse shoulder implants that were reported in the per; therefore, the reported event is due to user not following instructions.The reported event is confirmed from product return and the implanted products reported in the per.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: COMPR 3-IN-1 IMPACTOR
• Common Device Name: EXTREMITY INSTRUMENT
• 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: 21080820
• Report Number: 0001825034-2025-00045
• Device Sequence Number: 17850517
• Product Code: KWS
• UDI-Device Identifier: 00887868469978
• UDI-Public: (01)00887868469978(11)210823(10)459790
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K193373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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 Model Number: N/A
• Device Catalogue Number: 110028055
• Device Lot Number: 459790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2024
• 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: 12/10/2024
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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