MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE Ø3.0MM / L12MM; PLATE, FIXATION, BONE

Model Number	PLSL3012
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
It was reported that a 3.0mm locking screw went straight through the hole of an anchorage mtp fusion plate.While inserting the screw in the plate to achieve fixation the 3.0 locking screw did not lock into place and proceeded to go beyond the plate into the bone.A new screw was used with success.
Event or Problem Description
It was reported that a 3.0mm locking screw went straight through the hole of an anchorage mtp fusion plate.While inserting the screw in the plate to achieve fixation the 3.0 locking screw did not lock into place and proceeded to go beyond the plate into the bone.A new screw was used with success.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.However based on the reported event and the reported device and lot number, the likely root cause of this positioning issue has been identified as a design issue.A corrective action was initiated in order to increase the torque value which is necessary to bring the locking mechanism to failure.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LOCKING SCREW ANCHORAGE Ø3.0MM / L12MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9684859
• Report Number: 0008031020-2020-00319
• Device Sequence Number: 19686590
• Product Code: HRS
• UDI-Device Identifier: 07613252262114
• UDI-Public: 07613252262114
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083447
• 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): 03/25/2020

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 Model Number: PLSL3012
• Device Catalogue Number: PLSL3012
• Device Lot Number: Y28261
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1