MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW S.T. Ø4.5X34MM; PLATE, FIXATION, BONE

Catalog Number	601034
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2018
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
Trochanter fracture.It was treated fixation by omega.When the screw was inserted last one, the proximal screw head was broken at the final fastening.Impossible to remove it and remain the screw shaft in the body.
Event or Problem Description
Trochanter fracture.It was treated fixation by omega.When the screw was inserted last one, the proximal screw head was broken at the final fastening.Impossible to remove it and remain the screw shaft in the body.
Additional Manufacturer Narrative
The reported event that cortex screw s.T.4.5x34mm was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by too much applied mechanical force during final tightening.The device inspection revealed the following: only the screw head was received which is indeed completely broken of from the screw shaft.The damages on the bottom of the screw head clearly indicate that far too much torsional force was applied during final tightening (metal swarf/stripped of from the shaft).The screw shaft is still insitu and could not be removed though.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: CORTEX SCREW S.T. Ø4.5X34MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7896055
• Report Number: 0008031020-2018-00620
• Device Sequence Number: 13489831
• Product Code: HRS
• UDI-Device Identifier: 04546540085580
• UDI-Public: 04546540085580
• Combination Product (Y/N): N
• PMA/510(K) Number: K972323
• 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): 11/05/2018

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: 05/31/2022
• Device Catalogue Number: 601034
• Device Lot Number: L21058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 08/23/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/05/2018
• 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