MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE 3.0MM / L28MM; PLATE, FIXATION, BONE

Model Number	PLSL3028
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
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: "2 of the locking screws 3mm from the anchorage foot set have not locked into the plate and the head of another screw has broken off.".
Additional Manufacturer Narrative
Corrections: please refer to d9/h3, the device was not returned.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 was not possible because the lot number was not communicated.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.H3 other text : device disposition is unknown.
Event or Problem Description
As reported: "2 of the locking screws 3mm from the anchorage foot set have not locked into the plate and the head of another screw has broken off.".

• Brand Name: LOCKING SCREW ANCHORAGE 3.0MM / L28MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10931137
• Report Number: 0008031020-2020-02538
• Device Sequence Number: 2478184
• Product Code: HRS
• UDI-Device Identifier: 07613252262305
• UDI-Public: 07613252262305
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: PLSL3028
• Device Catalogue Number: PLSL3028
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1