MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L18MM; PLATE, FIXATION, BONE

Model Number 657318S

Device Problem Difficult to Insert (1316)

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

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, the locking screw did not lock when the locking screw was inserted into the plate.I checked the insertion angle and the depth of the drill, and reinserted it several times, but did not lock.I changed it to a screw of the same size and locked it when i put it back in.Doctor's view: "is the screw defective, the plate defective, or the screw too tight?" (b)(4) comment, "it is possible that the screw has contacted hard bone and changed the angle.".

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.Device disposition unknown.

Event Description

As reported, the locking screw did not lock when the locking screw was inserted into the plate.I checked the insertion angle and the depth of the drill, and reinserted it several times, but did not lock.I changed it to a screw of the same size and locked it when i put it back in.Doctor's view: "is the screw defective, the plate defective, or the screw too tight?" sr comment, "it is possible that the screw has contacted hard bone and changed the angle.".

• Brand Name: LOCKING SCREW VARIAX2 T10, FULL THREAD, 3.5MM / L18MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9936221
• MDR Text Key: 193430871
• Report Number: 0008031020-2020-01156
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 07613327086904
• UDI-Public: 07613327086904
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 657318S
• Device Catalogue Number: 657318S
• Device Lot Number: D34233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1