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

Model Number 661042S

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event 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.

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 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
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9532679
• MDR Text Key: 193336456
• Report Number: 0008031020-2019-02530
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 04546540708762
• UDI-Public: 04546540708762
• Combination Product (y/n): N
• PMA/PMN Number: K181091
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1