MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE 3.5MM / L14MM; PLATE, FIXATION, BONE

Model Number	PLSL3514
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded by hospital.
Event or Problem Description
It was reported that the two locking screws did not lock into the plate holes.

• Brand Name: LOCKING SCREW ANCHORAGE 3.5MM / L14MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 12391377
• Report Number: 0008031020-2021-00391
• Device Sequence Number: 3601938
• Product Code: HRS
• UDI-Device Identifier: 07613252262343
• UDI-Public: 07613252262343
• 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): 08/31/2021

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: PLSL3514
• Device Catalogue Number: PLSL3514
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1