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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during hip surgery, the instrument fractured into the patient.The implant was removed to retrieve the fractured piece.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).G3 report source: germany 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.Visual inspection of the returned product identified one of the welded pin cap at the distal end of the broach handle has fractured from the device.The fractured cap was not returned.Impact marks were found on both sides of the strike plate and on the handle near the part and lot etching.The square orientation feature is dinged and slightly deformed due repeated use.The welds on the trigger pin are fractured but remain intact.The trigger rotates around the axis within the confined space but does not actuate forward and back.The device history record was reviewed and no discrepancies 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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: EXACT OFFSET BROACH HANDLE NDL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9370987
• Report Number: 0001825034-2019-05340
• Device Sequence Number: 2901685
• Product Code: LXH
• 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): 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 855860
• 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: 11/12/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention