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

Model Number N/A

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00105.

Event Description

It was reported the drivers are "catching".The issue was discovered prior to use in a procedure.Additional drivers were used to complete the procedure successfully.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 confirmed.Visual inspection of the two (2) returned contra angle drivers was performed.For the driver with s/n 893200, it appears to be in good overall condition as well; there is some discoloration and brown residue noted at the driver collet.There is also some resistance when making one full rotation.The product was functionally tested using a contra angle traumone blade, cross-drive (part #sp-2379) to drive a 2.4 x 20 mm screw (part #73-2416) into a block of poplar wood.The product was able to drive the screw and functioned as intended, but there was significant sticking noted.Therefore, the complaint that the driver is "catching" is confirmed.The screwdriver was disassembled for further investigation and inspection; it was noted that there was more brown residue at the working end of the driver, though the origin cannot be determined.The driver could not be fully disassembled.The most likely underlying cause of the complaint is the gears being stripped, likely a result of excessive force from over torqueing by the surgeon.Device history record (dhr) was reviewed and no discrepancies were found.Investigation results concluded that the reported event was due to excessive force.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 report: 0001032347-2018-00105-1.

• Brand Name: 90° CONTRA ANGLE DRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 7303454
• MDR Text Key: 101378661
• Report Number: 0001032347-2018-00106
• 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: 08/06/2018

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: 893200
• Other Device ID Number: (01)00841036123130(10)893200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 06/19/2018
• Supplement Dates FDA Received: 08/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1