MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L30MM; SCREW, FIXATION, BONE

Model Number	661030S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.
Event or Problem Description
As reported: "axos proximal tibia procedure.The locking of the plate and screw was bad.This event probably occurred because the screw did not go straight into the opened hole.There may also be a problem with the bone quality of the patient.".
Additional Manufacturer Narrative
The reported event that locking screw axsos 3 ti 4.0mm / l30mm was alleged of issue ¿implant - insertion impaired¿ could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.However, based on the event, the probable cause could be user related like improper drilling, improper alignment while screw insertion etc.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "axos proximal tibia procedure.The locking of the plate and screw was bad.This event probably occurred because the screw did not go straight into the opened hole.There may also be a problem with the bone quality of the patient.".

• Brand Name: LOCKING SCREW AXSOS 3 TI 4.0MM / L30MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10042307
• Report Number: 0008031020-2020-01446
• Device Sequence Number: 14277827
• Product Code: HWC
• UDI-Device Identifier: 04546540685872
• UDI-Public: 04546540685872
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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: 06/30/2024
• Device Model Number: 661030S
• Device Catalogue Number: 661030S
• Device Lot Number: D35493
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 05/12/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR