MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM; PLATE, FIXATION, BONE

Model Number 657316S

Device Problems Positioning Failure (1158); Failure to Advance (2524)

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

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported: locking plate and locking screw did not lock.The screw was replaced with other one, and able to lock with the plate.The lot # of the screw which did not lock is unknown but the reporter requested to investigate if locking was unsuccessful with the same lot (3 of them).

Manufacturer Narrative

Correction: refer to h6 device code.The reported event that locking screw variax2 t10, full thread, 3.5mm / l16mm was alleged of 'implant - assembling / disassembling impaired' could not be confirmed, since the returned device is conforming to specifications and fully functional.The device was returned and does not present any visible damage to the threads which could have lead to an inability to screw with the plate.A functional test was made by screwing the returned screw with a random variax plate, and the device was able to lock with no problem, in various screw holes.The event can therefore not be confirmed.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

It was reported: locking plate and locking screw did not lock.The screw was replaced with other one, and able to lock with the plate.The lot # of the screw which did not lock is unknown but the reporter requested to investigate if locking was unsuccessful with the same lot (3 of them).

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L16MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10261165
• MDR Text Key: 200060997
• Report Number: 0008031020-2020-01882
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327086881
• UDI-Public: 07613327086881
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657316S
• Device Catalogue Number: 657316S
• Device Lot Number: D61274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2020
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1