MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXACT OFFSET BROACH HANDLE; GUIDE, SURGICAL, INSTRUMENT

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).Report source:(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 the rasp handle was broken through in the middle.No adverse events have been reported as a result of the malfunction.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported rasp handle impact plate fractured off.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: updated: d10; h2; h3; h6.Complaint sample was evaluated and the reported event was confirmed.One exact offset broach handle was returned and evaluated.Upon visual inspection the device had fracture at the weld on the strike plate.There are impact marks on the body and on both sides of the strike plate.Xrf analysis confirmed both segments of the broach handle to be consistent with 17-4 stainless steel alloy.The features of these fracture surfaces and mode align with those reported in summary of failure analysis of welded strike plates on broach handles.The common failure mode for the broach handles presented in this summary is tensile overload failure of the welded strike plate.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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: EXACT OFFSET BROACH HANDLE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10491816
• Report Number: 0001825034-2020-03428
• Device Sequence Number: 2567616
• Product Code: FZX
• UDI-Device Identifier: 00880304432260
• UDI-Public: (01)00880304432260
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2020

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: 31-555501
• Device Lot Number: 352570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 11/11/2020; 11/17/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 11/12/2020; 11/20/2020
• 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