MAUDE Adverse Event Report: STRYKER GMBH CORTEX SCREW AXSOS 3 Ø3.5MM / L24MM; PLATE, FIXATION, BONE

Model Number	661424
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that there was screw breakage during placement with use of dynamo.The rest of the screw was left in the patient.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the reported failure mode could be confirmed as the screw is broken at the threaded part, the functionality of the device cannot be given anymore.The broken area gives strong evidence of a brittle fracture, which is indicated by the lack of deformation and the shiny areas around the breakage.The fracture was most probably caused by an excessive bending or torsional load applied when inserting the screw.Based on investigation, the root cause was attributed to an user related issue.The failure was probably caused by excessive torsional oder bending load applied when inserting the screw.As a reminder, the instructions for use clearly state that: "it is imperative to engage the screw head into the plate using the torque limiter.Ensure that the screwdriver tip is fully seated in the screw head, but do not apply axial force during final tightening.If the screw stops short of final position, back up a few turns and advance the screw again (with torque limiter on)." 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 more information is provided, the case will be reassessed.
Event or Problem Description
The customer reported that there was screw breakage during placement with use of dynamo.The rest of the screw was left in the patient.

• Brand Name: CORTEX SCREW AXSOS 3 Ø3.5MM / L24MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14236711
• Report Number: 0008031020-2022-00214
• Device Sequence Number: 19918073
• Product Code: HRS
• UDI-Device Identifier: 07613252580331
• UDI-Public: 07613252580331
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123964
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 661424
• Device Catalogue Number: 661424
• Device Lot Number: D40861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female