MAUDE Adverse Event Report: STRYKER GMBH CANCELLOUS SCREW AXSOS 3 TI Ø4.0MM / L70MM / FULL THREAD; PLATE, FIXATION, BONE

Model Number	607370
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2020
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 is not available for return, device is still implanted.
Event or Problem Description
It was reported, a doctor threaded a 70mm fully threaded 4.0 x 70mm cancellous axsos 3 screw entirely through the proximal hole of the plate where the targeter for distal screws attaches.Remained implanted.
Event or Problem Description
It was reported, a doctor threaded a 70mm fully threaded 4.0 x 70mm cancellous axsos 3 screw entirely through the proximal hole of the plate where the targeter for distal screws attaches.Remained implanted.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.However, the complaint event states that the "doctor threaded a cancellous axsos 3 screw entirely through the proximal hole of the plate where the target for distal screws attaches".The operative technique explains that the placement of the targeting arm should be performed before the insertion of the screws.A review of the device history was not possible because the lot number was not communicated.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 attributed to be user related.The failure was caused by not following the instructions given on the operative technique.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: CANCELLOUS SCREW AXSOS 3 TI Ø4.0MM / L70MM / FULL THREAD
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9613204
• Report Number: 0008031020-2020-00111
• Device Sequence Number: 10899535
• Product Code: HRS
• UDI-Device Identifier: 07613252578673
• UDI-Public: 07613252578673
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 03/31/2020

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 Model Number: 607370
• Device Catalogue Number: 607370
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/01/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR