MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L46MM; SCREW, FIXATION, BONE

Model Number	661046S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2020
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: "event details: when fixing the screw to the plate, it was confirmed that there was metal lint.Physician's point of view: the screws were inserted at a difficult angle, so the metals rubbed against each other and were scraped.".
Event or Problem Description
As reported: "event details: when fixing the screw to the plate, it was confirmed that there was metal lint.Physician's point of view: the screws were inserted at a difficult angle, so the metals rubbed against each other and were scraped.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the returned device is a circular metallic wire, probably from the screw thread that makes the locking mechanism of the screw.The wire was considered to be a result of the screw and not the plate, since the length received is too long to be a result of the locking mechanism of the plate.The debris was most probably generated as a result of an inadequate angulation of the screw, which lead to the two metals of the plate and screw scratching against each other.The debris could not have resulted from manufacturing, since the devices are inspected before packing.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.

• Brand Name: LOCKING SCREW AXSOS 3 TI 4.0MM / L46MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10339751
• Report Number: 0008031020-2020-01989
• Device Sequence Number: 19627619
• Product Code: HWC
• UDI-Device Identifier: 04546540708786
• UDI-Public: 04546540708786
• Combination Product (Y/N): N
• PMA/510(K) Number: K200398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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 Expiration Date: 12/31/2023
• Device Model Number: 661046S
• Device Catalogue Number: 661046S
• Device Lot Number: Y60433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR