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

Model Number	657318S
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem 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.".
Additional 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 or Problem 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
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9936221
• Report Number: 0008031020-2020-01156
• Device Sequence Number: 2497007
• Product Code: HRS
• UDI-Device Identifier: 07613327086904
• UDI-Public: 07613327086904
• 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): 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 657318S
• Device Catalogue Number: 657318S
• Device Lot Number: D34233
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1