MAUDE Adverse Event Report: STRYKER GMBH NON LOCKING SCREW ANCHORAGE 3.0MM / L16MM; PLATE, FIXATION, BONE

Model Number	PLSS3016
Medical Device Problem Code	Fracture (1260)
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
The reported event could be confirmed.The device inspection revealed the following: the screw head has separated completely from the screw body, most probably because of the exertion of an important torsional force during insertion.The screw body was not returned, therefore a larger breakage surface could not be analyzed.Based on investigation, the root cause was attributed to be user related.The failure was most probably caused by an overtorque on the screw head.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.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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: NON LOCKING SCREW ANCHORAGE 3.0MM / L16MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10931095
• Report Number: 0008031020-2020-02532
• Device Sequence Number: 16833715
• Product Code: HRS
• UDI-Device Identifier: 07613252262688
• UDI-Public: 07613252262688
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/17/2021

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: PLSS3016
• Device Catalogue Number: PLSS3016
• Device Lot Number: D48889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1