MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL PIN AND SCREW INSERTER; EXTRACTOR

Model Number	00-5901-021-00
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the returned product identified signs of repeated use (nicked/gouged) and the hex feature was found to be fractured with all pieces returning.Device history record was reviewed and no discrepancies related 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
It was reported that during an initial knee procedure, a screw driver fractured during screw insertion.No adverse events have been reported as a result of this malfunction.The surgery was completed with a second instrument without complication.

• Brand Name: DRILL PIN AND SCREW INSERTER
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14395259
• Report Number: 0001822565-2022-01414
• Device Sequence Number: 5641348
• Product Code: HWB
• UDI-Device Identifier: 00889024201637
• UDI-Public: (01)00889024201637(10)64519747
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

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: 00-5901-021-00
• Device Catalogue Number: 00590102100
• Device Lot Number: 64519747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male