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

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4). Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported two (2) contra angle drivers do not turn properly. This was identified by the sales distributor upon receipt of the drivers. There was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. Visual inspection of the two contra angle screwdrivers (part# 24-1189, lot# 421480) showed signs of moderate wear, with minor scratching and discoloration on the bodies of the screwdrivers. Functional testing showed one screwdriver was sticking during rotation and the other would not rotate a blade. The driver s were disassembled for further inspection and it was found that the internal gears were rusty and some metal shavings fell out during disassembly. Device history record (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 excessive force by over torqueing. In the warnings and precautions section of the instructions for use (ifu) for this product it is stated ¿avoid undue stress or strain when handling or cleaning instruments. ¿ the discoloration is most likely due to residual from the cleaning process. 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: 90° CONTRA ANGLE DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7558470
• MDR Text Key: 109759503
• Report Number: 0001032347-2018-00324
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: PK142823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 24-1189
• Device Lot Number: 421480
• Other Device ID Number: (01)00841036123130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No