MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE 3.0MM / L10MM; PLATE, FIXATION, BONE

Model Number	PLSL3010
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
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 was discarded.
Event or Problem Description
It was reported that the 3.0mm screw did not lock into the plate.Additionally reported: case was completed by using a new screw.There was predrilling performed, the bone was soft.

• Brand Name: LOCKING SCREW ANCHORAGE 3.0MM / L10MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10931520
• Report Number: 0008031020-2020-02546
• Device Sequence Number: 2478185
• Product Code: HRS
• UDI-Device Identifier: 07613252262091
• UDI-Public: 07613252262091
• 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
• Report Date (Section B): 12/01/2020

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1