MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM COMP RVS GLEN TRAY IMPTR; IMPACTOR

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign event (b)(6).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 the instrument fractured during use.No patient harm reported per surgeon.No further information is available at the time of this reporting.
Additional Manufacturer Narrative
No device was returned.Visual examination of the provided pictures identified the strike plate fractured from the impactor body.Complaint is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.However, it is known this device was manufactured prior to design improvements.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 information is available at the time of this reporting.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Corrections to d4 and h4.Upon reassessment of the reported event, it was determined that it was not reportable.The initial report was forwarded in error and should be voided.If any further information is found that 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
It was reported that during a procedure, the instrument fractured at the strike plate while hammering the impactor.The surgeon considers this a result of natural wear and tear.There was no impact on the patient.Attempts have been made, and no further information has been provided.

• Brand Name: 25MM COMP RVS GLEN TRAY IMPTR
• Common Device Name: IMPACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8959968
• Report Number: 0001825034-2019-03926
• Device Sequence Number: 16788223
• Product Code: KWS
• UDI-Device Identifier: 00880304532298
• UDI-Public: (01)00880304532298(11)150716(10)3058598
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K120121
• 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
• Report Date (Section B): 03/13/2025

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: 405809
• Device Lot Number: 3058598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 02/21/2025
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 09/20/2019; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2015
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown