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

Model Number 657312S

Device Problems Material Fragmentation (1261); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Additional information reported that: after drilling and before inserting the screw, drilling into the next screw hole was made and then inserting the screw.This caused the plate to shift and the drill hole to be shifted from the initial position, which seemed to have caused locking failure.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by misalignment of the implant before screw insertion.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device discarded.

Event Description

It was reported, when the locking screw was inserted during the variax fibula operation, locking failure occurred.It seemed that the angle of the screw was too inclined, but the drill guide was in the normal range.When the screw was turning to lock, a piece of metal came out of between the plate and the screw.A new locking screw of the same size was opened and reinserted, and it was locked.The operation is completed successfully.Additional information reported that: after drilling and before inserting the screw, drilling into the next screw hole was made and then inserting the screw.This caused the plate to shift and the drill hole to be shifted from the initial position, which seemed to have caused locking failure.Customer / sales rep confirmed that no further information is available.

Manufacturer Narrative

Update: refer to h6 device code.

Event Description

It was reported, when the locking screw was inserted during the variax fibula operation, locking failure occurred.It seemed that the angle of the screw was too inclined, but the drill guide was in the normal range.When the screw was turning to lock, a piece of metal came out of between the plate and the screw.A new locking screw of the same size was opened and reinserted, and it was locked.The operation is completed successfully.Additional information reported that: after drilling and before inserting the screw, drilling into the next screw hole was made and then inserting the screw.This caused the plate to shift and the drill hole to be shifted from the initial position, which seemed to have caused locking failure.Customer / sales rep confirmed that no further information is available.

• Brand Name: LOCKING 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: 9702276
• MDR Text Key: 193365601
• Report Number: 0008031020-2020-00346
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327086829
• UDI-Public: 07613327086829
• 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: 03/24/2020

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: 657312S
• Device Catalogue Number: 657312S
• Device Lot Number: D50232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1