MAUDE Adverse Event Report: BIOMET MICROFIXATION 90° CONTRA ANGLE DRIVER; SCREWDRIVER

Model Number N/A

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Unique identifier (udi) #: (b)(4).Foreign country: (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported one contra angle screwdriver was a bit bumpy during a procedure on the left side.The function was okay, but the driver didn't run smooth.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.

Event Description

This follow-up is being submitted to relay additional information.

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The contra angle driver was visually evaluated and found to be in good overall condition with minimal wear.Functional testing showed that the driver was frequently sticking during rotation.The complaint is confirmed.The driver was disassembled for further inspection and it was found that the internal gears were stripped and metal shavings fell out during disassembly.Dhr was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the gears being stripped, likely resulting from torque in excess of what is required to fixate the screw.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.

• Brand Name: 90° CONTRA ANGLE DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8179094
• MDR Text Key: 131320943
• Report Number: 0001032347-2018-00880
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/09/2019

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: 24-1189
• Device Lot Number: 591220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1