MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE Ø3.0MM / L10MM; PLATE, FIXATION, BONE

Model Number	PLSL3010
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2019
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: "locking screw went through plate.A new screw was used and it fit perfectly according to the surgeon." also reported: "the plate was implanted and so it would not be possible [to obtain catalog & lot #].It certainly wasn¿t an issue with the plate given that the next screw fit perfectly according to the surgeon.The surgeon took the screw out and replaced it with another and so a delay of say 1 minute occurred." procedure was otherwise completed successfully with no adverse consequences reported.
Additional Manufacturer Narrative
The reported event could be confirmed.Visual inspection: the visual inspection showed that the screw is in a good state.No traces of damages were noticed.Based on the specification that this screw was manufactured to, as well as a previous root cause investigation and corrective action that was raised for this screw issue, the 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.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.
Event or Problem Description
As reported: "locking screw went through plate.A new screw was used and it fit perfectly according to the surgeon." also reported: "the plate was implanted and so it would not be possible [to obtain catalog & lot #].It certainly wasn¿t an issue with the plate given that the next screw fit perfectly according to the surgeon.The surgeon took the screw out and replaced it with another and so a delay of say 1 minute occurred." procedure was otherwise completed successfully with no adverse consequences reported.

• Brand Name: LOCKING SCREW ANCHORAGE Ø3.0MM / L10MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9153543
• Report Number: 0008031020-2019-01348
• Device Sequence Number: 2836855
• Product Code: HRS
• UDI-Device Identifier: 07613252262091
• UDI-Public: 07613252262091
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/07/2020

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: PLSL3010
• Device Catalogue Number: PLSL3010
• Device Lot Number: Y01406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1