MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL BROACH IMPACTOR; INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign (b)(6).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 during a total knee arthroplasty the tibial broach handle fractured during the procedure.No pieces fell into the patient and the procedure was completed without delay.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).The complaint is confirmed.Visual examination of the provided pictures identified the head of the instrument was fractured.The picture shows signs of use.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.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
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; g3; g4; g6; h1; h2; h3; h6 complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified signs of repeated use (impaction marks, gouges, and nicks).The weld which connects the rod head with the rod shaft was fractured.The potential field age of this instrument is 4 years and 1 month.Device history record (dhr) was reviewed and no discrepancies were found.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
No further event information available at the time of this report.

• Brand Name: TIBIAL BROACH IMPACTOR
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11156753
• Report Number: 0001822565-2021-00100
• Device Sequence Number: 18993221
• Product Code: HWA
• UDI-Device Identifier: 00889024207707
• UDI-Public: (01)00889024207707(10)63561564
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2021

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: 00595109000
• Device Lot Number: 63561564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 02/23/2021; 05/03/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/25/2021; 05/04/2021
• 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