MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 TI 3.5MM / L34MM; PLATE, FIXATION, BONE

Model Number	661434
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/23/2020
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
Customer reported that : "while the doctor was inserting an axos ancillary instrument set plate, one of the cortex screws (part number: 661434) broke.The body of the screw remained in the patient while the head detached.The patient is fine, the body of the screw will be removed along with the plate.".
Additional Manufacturer Narrative
The reported event that cortex screw axsos 3 ti ø3.5mm / l34mm was alleged of issue ¿implant - breakage intra-operative¿ could be confirmed, since the product was returned and was found to be broken.The device inspection revealed the following: the received cortex screw having only the head part, the other part is still in the patient¿s bone.The surface of the head has multiple scratches and dents.The edges of the hexagon are deformed.The fracture surface indicated that towards the high axial loading during the final insertion.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 manufacturing or design related problems were found during the investigation.The operative technique clearly instructs user that: ¿ensure that the screwdriver tip is fully seated in the screw head, but do not apply axial force during final tightening.In the extreme event of broken or stripped screws,¿ based on the investigation the root cause was attributed to a user related issue.The failure was caused due to the high axial loading during the final insertion.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Customer reported that: "while the doctor was inserting an axos ancillary instrument set plate, one of the cortex screws (part number: 661434) broke.The body of the screw remained in the patient while the head detached.The patient is fine, the body of the screw will be removed along with the plate.".

• Brand Name: CORTEX SCREW AXSOS 3 TI 3.5MM / L34MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9844980
• Report Number: 0008031020-2020-00726
• Device Sequence Number: 19492218
• Product Code: HRS
• UDI-Device Identifier: 07613252580386
• UDI-Public: 07613252580386
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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 Expiration Date: 12/31/2023
• Device Model Number: 661434
• Device Catalogue Number: 661434
• Device Lot Number: Y61193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1