MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 3 TI 4.0MM / L38MM; PLATE, FIXATION, BONE

Model Number	661038
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2020
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: "the screws had no hold in the plate.".
Event or Problem Description
As reported: "the screws had no hold in the plate.".
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: one humeral plate and 3 screws were returned.It was noticed that the threads of the screw holes on the proximal side of the plate are highly deformed, probably because of an inadequate insertion of the screws.This deformation of the screw holes could have led to the inability of the surgeon to lock the screws on the proximal part of the plate.One of the screws also shows a high plastic deformation of the locking mechanism under the screw head.This confirms the hypothesis that the screws were inserted with an inadequate angle (an angle superior to the 20° cone allowed with the axsos screws).The returned screws could indeed not be locked into the proximal screw holes on the plate, which shows a deformation of the threads based on investigation, the root cause was attributed to be user related.The failure was caused by the insertion of the screws with an angle superior to what is allowed (20°).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 / L38MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10564225
• Report Number: 0008031020-2020-02253
• Device Sequence Number: 2778926
• Product Code: HRS
• UDI-Device Identifier: 07613252579847
• UDI-Public: 07613252579847
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123964
• 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): 11/17/2020

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: 661038
• Device Catalogue Number: 661038
• Device Lot Number: D51644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR