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 rasp handle impact plate broken off.No adverse events have been reported as a result of the malfunction.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
Visual inspection confirmed the weld between the front and rear body to be fractured with the cable still intact.The cable was cut during the evaluation.The handle is discolored and exhibits impact marks on the strike plate consistent with a multiple use instrument.The square orientation feature on the distal end of the rasp has been lightly deformed over repeated use.The device has a potential field age of approximately 1 year.Device was sent for further analysis.Fracture surface artifacts suggest the overload failure mode with multiple fracture initiation sites on the right side of the device.Xrf analysis found the material of both the proximal and distal components to be consistent with 17-4 stainless steel alloy.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: 10491813
• Report Number: 0001825034-2020-03430
• Device Sequence Number: 16786016
• 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
• Report Date (Section B): 11/19/2020

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: 11/17/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 11/19/2020
• 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