MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L42MM; SCREW, FIXATION, BONE

Model Number	661042S
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
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
The axsos locking screw did not advance in the direction of drilling or tapping.It was not locked to the plate.When i opened and inserted a new one, i was able to insert it well.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the threads under the screw head are highly deformed plastically, such that it is normal that the screw can not be locked into a plate anymore.The threads are ¿flattened¿ proving that the screw was not inserted properly.Some possible causes for this kind of failure mode: the screw insertion was made with a wrong angulation which caused jamming and thread damage.As a reminder, the axsos screws only allow a 10° angulation.The insertion of the screw was attempted multiple times, which caused thread damage.The screw insertion was made using fast speed power tool.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.Based on investigation, the root cause was therefore attributed to be user related issue.If any further information is provided, the investigation report will be updated.
Event or Problem Description
The axsos locking screw did not advance in the direction of drilling or tapping.It was not locked to the plate.When i opened and inserted a new one, i was able to insert it well.

• Brand Name: LOCKING SCREW AXSOS 3 TI 4.0MM / L42MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9532679
• Report Number: 0008031020-2019-02530
• Device Sequence Number: 11457524
• Product Code: HWC
• UDI-Device Identifier: 04546540708762
• UDI-Public: 04546540708762
• Combination Product (Y/N): N
• PMA/510(K) Number: K181091
• 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): 02/26/2020

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: 10/31/2023
• Device Model Number: 661042S
• Device Catalogue Number: 661042S
• Device Lot Number: Y49140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1