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

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	11/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Foreign report source: (b)(6).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 the femoral impactor came apart during impaction.The plastic head was also cracked.This had no effect on patient but surgeon required another instrument to complete the procedure.There is no additional information at this time.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Visual examination of the returned product confirmed femoral inserter and extractor was disassembled and fractured stop pin.Also, the impaction or chisel-like mark was noted in the head of the instrument.The impactor pad was fractured.Impactor pad and femoral inserter and extractor was submitted for further analysis.The analysis of the impactor pad identified the fracture was consistent with the device fractures analyzed in zrm_wa_0507_19, which indicates overload failure or low cycle fatigue culminating in the overload failure.The analysis of the femoral inserter and extractor identified the fracture of the stop pin was suspected due to sheared overload.The material analysis found consistent with the print specification.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.

• Brand Name: FEMORAL INSERTER / EXTRACTOR
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9480321
• Report Number: 0001822565-2019-05298
• Device Sequence Number: 234230
• Product Code: MBH
• UDI-Device Identifier: 00889024232860
• UDI-Public: (01)00889024232860
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172524
• 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): 05/29/2020

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: 42509909200
• Device Lot Number: 63871202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 05/29/2020
• 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