MAUDE Adverse Event Report: ZIMMER BIOMET, INC. QUICK-CONNECT HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during total knee arthroplasty the quick connect handle fractured off while impacting the definitive femur.There is no additional information available at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual evaluation of the returned instrument shows sign of repeated use.The impactor head was fractured.Device was submitted for further analysis.Analysis determined that the fracture might be due to overload.Material analysis conforming to print.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot 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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: QUICK-CONNECT HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10361630
• Report Number: 0001822565-2020-02795
• Device Sequence Number: 19408525
• Product Code: LXH
• UDI-Device Identifier: 00889024201682
• UDI-Public: (01)00889024201682
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/02/2020

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: 00590103400
• Device Lot Number: 63551557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/12/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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