MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL INSERTER / EXTRACTOR; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation of the returned device found that the operates as intended.The device exhibited usage mark however dimensional analysis found the device to be within specification.Functional dimensions were performed and found to be acceptable.The evaluation of device found that the device operated within specification and hence no issue with the device was seen.The complaint cannot be confirmed.No corrective actions, preventive actions, or field actions resulted after investigation of this event.
Event or Problem Description
It was reported the femoral inserter/extractor handle is broken.The spring isn't working anymore.No impact on patient.

• Brand Name: FEMORAL INSERTER / EXTRACTOR
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11380751
• Report Number: 0001822565-2021-00490
• Device Sequence Number: 11707564
• Product Code: JWH
• UDI-Device Identifier: 00889024232860
• UDI-Public: (01)00889024232860(10)63552213
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2021

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: 42509909200
• Device Lot Number: 63552213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/25/2021
• 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