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

Model Number N/A

Device Problems Defective Device (2588); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Medical product: biomet microfixation temporary fixation screw catalog #: 76-0017, lot #: 703610.Complaint sample was evaluated and the reported event was confirmed.Functional testing was done on the driver by rotating the knob, which showed that the driver was sticking during rotation.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00356 & 0001032347-2019-00217-1.

Event Description

It was reported by the sales associate that a temporary fixation screw became stuck in one driver and another driver was hard to turn.No adverse events have been reported as a result of the malfunction.

• Brand Name: 90° CONTRA ANGLE DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: alan munoz ; 1520 tradeport drive; jacksonville, FL 32218 ; 9043677142
• MDR Report Key: 8770061
• MDR Text Key: 172238989
• Report Number: 0001032347-2019-00355
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00841036123130
• UDI-Public: 00841036123130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• 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: 548890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1