MAUDE Adverse Event Report: STRYKER GMBH BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM; PLATE, FIXATION, BONE

Catalog Number 657412S

Device Problems Flaked (1246); Material Fragmentation (1261); Detachment of Device or Device Component (2907)

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

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation, additional information will be provided in a supplemental report.

Event Description

While driving a bone screw into a distal fibula plate, metal wires(chips) came from the screw.No surgical delay or adverse consequences were reported.Procedure was completed successfully.

Manufacturer Narrative

The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible inadequate angulation during screw insertion.The device inspection revealed the following: some metal shaving (coils) on both returned screws is clearly evident.The metal coils are still attached to the screw bodies.The remaining coil on the screw with lot y44299 is thin, whereas the coil on lot y36493 is rather thick.Also the abrasions on both screws are almost for the entire length to the second last thread turn.Which indicates that the positioning of the plate and the predrilled hole were initially not line up accordingly and the applied angle during screw insertion resulted in the screw abrasions (coil).It looks as the plate was repositioned but still not enough in order to insert the second screw as there were still some thinner abrasions evident.Finally new screw(s) was inserted without any further problems (possibly after realigning the plate).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.If any further information is provided, the investigation report will be updated.

Event Description

While driving a bone screw into a distal fibula plate, metal wires(chips) came from the screw.No surgical delay or adverse consequences were reported.Procedure was completed successfully.

• Brand Name: BONE SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L12MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8434674
• MDR Text Key: 139457876
• Report Number: 0008031020-2019-00276
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327073768
• UDI-Public: 07613327073768
• 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: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 657412S
• Device Lot Number: Y44299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1