MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL BROACH IMPACTOR

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 Description

It was reported that a knee instrument fractured during a surgery.While the surgeon was making the keel for the tibia one of the proximal parts fractured.No piece fell into the patient¿s body.There was no harm to the patient.This instrumentation was used for seven to ten years or more.There is no additional information available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the provided picture found the strike plate has fractured off.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.The device has a potential field age of 8 years with an unknown number or uses.The provided picture is not clear enough to determine the condition of the device, therefore a definitive root cause cannot 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 Description

No additional information reported.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Visual examination of the returned device found signs of repeated use (nicked and gouged) the weld that connects sub components 00595199004 and 00595199002 has fractured.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.The device has a potential field age of eight years and exhibits signs of repeated use.The root cause of the reported event is attributed to wear and tear from repeated use over time.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: TIBIAL BROACH IMPACTOR
• Type of Device: IMPACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10771677
• MDR Text Key: 214164720
• Report Number: 0001822565-2020-03697
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00595109000
• Device Lot Number: 61976280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 11/25/2020; 01/28/2021
• Supplement Dates FDA Received: 12/04/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1