MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI Ø3.5MM / L30MM; PLATE, FIXATION, BONE

Model Number	661430
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/09/2018
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
While tightening the screw to the plate, the screw has passed though the oval hole on the plate.Noticed on x-ray check of screw position.Extra procedure time required to remove and reduce the fracture 45 mins.
Additional Manufacturer Narrative
Correction unk lot# the reported event that cortex screw axsos 3 ti ø3.5mm / l30mm was alleged of 'poor fixation' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by inadequate / excessive force during screw insertion.The device inspection revealed the following: the plate as such is slightly deformed.It is also clearly evident through the damages on the plate as well on the screw that far too much mechanical force has caused these damages.The screw had been forced through the plate hole, the damages on the screw and the plate clearly indicate that.Possibly encountered hard bone.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.If any further information is provided, the investigation report will be updated.
Event or Problem Description
While tightening the screw to the plate, the screw has passed though the oval hole on the plate.Noticed on x-ray check of screw position.Extra procedure time required to remove and reduce the fracture 45mins.

• Brand Name: CORTEX SCREW AXSOS 3 TI Ø3.5MM / L30MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7475052
• Report Number: 0008031020-2018-00332
• Device Sequence Number: 13536676
• Product Code: HRS
• UDI-Device Identifier: 07613252580362
• UDI-Public: (01)07613252580362
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 08/08/2018

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 Model Number: 661430
• Device Catalogue Number: 661430
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 08/08/2018
• 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
• Patient Age: 44 YR