MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM; PLATE, FIXATION, BONE

Model Number 657314S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Distal fibula fracture.Using a variax fibula plate (4 holes), a 3.5 mm (14 mm long) locking screw was inserted into the most distal hole.When the screw head was buried in the plate, a piece of metal flew from the contact between the plate and the screw.The screw was removed once, and the metal piece was also removed from the body.The screw was replaced with a same size one, and the screw was able to be successfully tightened.

Manufacturer Narrative

The reported event could be confirmed.The device inspection revealed the following: some turns of the locking threads are indeed damaged / shaved off.One section of the locking thread is completely missing.Unfortunately the mentioned metal shaving has not been returned for investigation.It should be noted, the tests showed that the screw could be locked in position, despite the damages of the locking threads but not to secure though.The decision to replace the screw was the correct process to follow.Possible cause of these damages could have been as the locking screw was positioned on an unfavorable angle so that the material was getting shaved off.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible inadequate angulation / positioning during screw insertion.If any further information is provided, the investigation report will be updated.

Event Description

Distal fibula fracture.Using a variax fibula plate (4 holes), a 3.5 mm (14 mm long) locking screw was inserted into the most distal hole.When the screw head was buried in the plate, a piece of metal flew from the contact between the plate and the screw.The screw was removed once, and the metal piece was also removed from the body.The screw was replaced with a same size one, and the screw was able to be successfully tightened.

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L14MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9674105
• MDR Text Key: 193356589
• Report Number: 0008031020-2020-00313
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327086850
• UDI-Public: 07613327086850
• Combination Product (y/n): N
• PMA/PMN Number: K132502
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657314S
• Device Catalogue Number: 657314S
• Device Lot Number: D50936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 02/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1