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

Model Number N/A

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical product: biomet microfixation ribfix blu temporary fixation screw, catalog #: 76-0017, lot #: ni.Therapy date: (b)(6) 2018.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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00123, 0001032347-2018-00124, and 0001032347-2018-00188.

Event Description

It was reported a contra angle driver had bits stuck.It was later reported they miscounted, three drivers failed during the rib fixation procedure.There was no injury to the patient and a delay of approximately five (5) minutes.The procedure was completed using back-up instruments.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.A visual inspection of the three (3) returned drivers shows fair overall condition as there are signs of use including scratches and discoloration.Of note, one driver 24-1189 lot # 407790 had a 76-0017 temporary fixation screw inserted in the collet, while a second driver 24-1189 lot # 008100 had a sp-2379 contra angle driver blade inserted in the collet when they were returned.The third driver 24-1189 lot # 820410 was not returned with a screw or blade in the collet.The 76-0017 temporary fixation screw has damage noted to the threads, showing signs of insertion.The sp-2379 contra angle driver blade shows signs of use with damage to the tip of the blade.The 24-1189 driver lot # 407790 with the 76-0017 temporary fixation screw was able to be easily removed from and inserted into the collet.The returned 76-0017 temporary fixation screw was tested with the driver that did not have a blade or screw in the collet (24-1189 driver lot # 820410) and this too was able to be inserted into and removed from the collet easily.Therefore, the portion of the complaint that two (2) 24-1189 90 degree contra angle screwdrivers had bit 76-0017 contra angle temporary fixation screw get stuck in them is unconfirmed.The 24-1189 driver lot # 008100 with the sp-2379 contra angle driver blade was difficult to remove from the collet and was only able to be done after disassembly of the driver.The portion of the complaint that one (1) 24-1189 90 degree contra angle screwdriver had a sp-2379 contra angle t1 blade, x-drive get stuck is confirmed.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to the manufacturers inspection methods.The supplier used blades, and not the min/max gage, to design the collet resulting in the collet failing the max gage inspection.Based on the manufacturing date of the three (3) contra angle drivers, this root cause is applicable to the three (3) contra angle drivers.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2018-00123-2, 0001032347-2018-00124-1, and 0001032347-2018-00188-1.

• Brand Name: 90° CONTRA ANGLE DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7413605
• MDR Text Key: 105382825
• Report Number: 0001032347-2018-00189
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 24-1189
• Device Lot Number: 407790
• Other Device ID Number: (01)00841036123130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1