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)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign country (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 with no adverse consequence to the patient or procedure.No further information is available at the time of this reporting.
Additional Manufacturer Narrative
Upon receipt of additional information, it has been determined that this event is not reportable.The initial report was forwarded in error and should be voided.
Event or Problem Description
Upon receipt of additional information, it has been determined that this event is not reportable.The initial report was forwarded in error and should be voided.

• 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
• MDR Report Key: 9501524
• Report Number: 0001825034-2019-05594
• Device Sequence Number: 2967180
• Product Code: KWS
• UDI-Device Identifier: 00880304532298
• UDI-Public: 00880304532298
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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: 2547194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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