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

Catalog Number	110028055
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the product was fractured during the procedure.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.
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 information.Visual examination of the provided photograph identified that the tip of the impactor is broken.Part 110028055 is supposed to have a black tip, however, this instrument was returned with a gray tip assembled.Evaluation of the returned device shows wear and damage and not all of the pieces of the broken tip were returned.The features of the fracture surface visually align with an overload fracture failure mode.Review of the device history record(s) identified no deviations or anomalies during manufacturing.The tip of the impactor switched is epoxied, and therefore not to be disassembled for sterilization.However, it is unknown if this contributed to the reported event.A definitive root cause cannot be determined.The reported event is confirmed by returned product.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.

• Brand Name: COMPR 3-IN-1 IMPACTOR
• Common Device Name: EXTREMITIES, 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: 18037842
• Report Number: 0001825034-2023-02546
• Device Sequence Number: 11569987
• Product Code: KWS
• UDI-Device Identifier: 00880304731301
• UDI-Public: (01)00880304731301(11)170718(10)196580
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup,Followup
• Report Date (Section B): 02/22/2024
• 2 Devices were Involved in the Event: 1 2

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: 196580
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 11/02/2023; 11/29/2023; 02/19/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 11/30/2023; 12/27/2023; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2017
• 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: Male