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

Model Number N/A

Device Problems Device Inoperable (1663); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical device - biomet microfxation traumaone system contra angle cross-drive blade catalog #: sp-2379, lot: 797520.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 reports: 0001032347-2018-00109 and 0001032347-2018-00110.

Event Description

It was reported the "contra angle driver broke after two full rotations.You could hear the gears clicking and the driver failed to turn the blade." two additional contra angle drivers had blades that would get stuck irreversibly during the case.There was no injury and no delay.The surgeon completed the procedure using the second contra angle driver in the set.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 part of the reported event was confirmed.A visual inspection of the returned drivers shows good overall condition for all three (3) drivers; there are minor scratches on all but no significant discoloration.The returned blade shows normal signs of use.Of note, the blade was returned disengaged from the drivers.The returned blade was successfully inserted into the collet and removed from all three (3) returned drivers, therefore the portion of the complaint that two (2) of the returned contra angles having blades that would get stuck irreversibly is unconfirmed.The most likely underlying cause cannot be determined.Functional testing was performed with the returned parts to drive a 2.4 x 16 mm screw(part # 73-2416) into a block of poplar wood.The driver with lot 727930 was able to turn the blade and insert the screw; lots 329420 and 008100 were not able to turn the blade and insert the screw, while there was also clicking heard.Lots 329420 and 008100 were disassembled for further investigation and inspection; it was noted that the internal gears were stripped and there were metal shavings 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 a result of excessive force from over torqueing by the surgeon.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: 0001032347-2018-00109-1 and 0001032347-2018-00110-1.

• Brand Name: 90° CONTRA ANGLE DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7311283
• MDR Text Key: 101701129
• Report Number: 0001032347-2018-00111
• 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: distributor,health profession
• 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: 03/02/2018
• 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: 329420
• Other Device ID Number: (01)00841036123130(10)727930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1