MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI Ø3.5MM / L46MM; PLATE, FIXATION, BONE

Catalog Number	661446
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The screw was screwed in manually after proper pre-drilling.The head of the screw broke off.The screw remained in the patient.The broken screw head has been recovered and is available for examination.No revision planned.
Additional Manufacturer Narrative
Correction: brand name, model #: gtin.The reported event could be confirmed.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by far too much applied torsional force during screw insertion.The device inspection revealed the following: the returned broken part of the screw clearly shows very strong deformation / damages of the inner torx.This clearly indicates that far too much torsional force beyond its calculated capability had been applied during screw insertion.The broken surface shows the structures of a typical ductile overload breakage.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.
Event or Problem Description
The screw was screwed in manually after proper pre-drilling.The head of the screw broke off.The screw remained in the patient.The broken screw head has been recovered and is available for examination.No revision planned.

• Brand Name: CORTEX SCREW AXSOS 3 TI Ø3.5MM / L46MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8537085
• Report Number: 0008031020-2019-00367
• Device Sequence Number: 360608
• Product Code: HRS
• UDI-Device Identifier: 07613252580478
• UDI-Public: 07613252580478
• Combination Product (Y/N): N
• 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): 06/07/2019

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 Catalogue Number: 661446
• Device Lot Number: V21486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Weight: 85