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

Model Number	657312S
Medical Device Problem Codes	Material Fragmentation (1261); Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Update: refer to h6 device code.
Event or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9702276
• Report Number: 0008031020-2020-00346
• Device Sequence Number: 11452082
• Product Code: HRS
• UDI-Device Identifier: 07613327086829
• UDI-Public: 07613327086829
• Combination Product (Y/N): N
• PMA/510(K) Number: K132502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 657312S
• Device Catalogue Number: 657312S
• Device Lot Number: D50232
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1