MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER AXSOS T15 4.0MM LOCKING SET; SCREW, FIXATION, BONE

Model Number	702747
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
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
As reported: "damaged wrench during the procedure in the placement of the screw, breaking the tip in the tightening of the screw.".
Additional Manufacturer Narrative
Please note the correction to d4 lot#, h6 clinical signs and h6 health impact codes.The reported event could be confirmed, since the device was returned on 26-aug-2022 for evaluation and matches the reported failure mode.The device inspection revealed the following: the identification of the device is confirmed based on the lot number and the catalog number marked.The visual inspection has shown that the tip of the received screwdriver is broken off due to clear torsional overload.Indeed, the torsion lines of the breakage were clearly visible, even to the naked eye.A microscope picture showed the torsion lines of the breakage even more clearly.Over torque can therefore be defined as the root cause for this case.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.As per the dimensional inspection and hardness testing, the returned device was found to be within specification.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.Based on investigation, the root cause was finally attributed to a user related issue.The failure was caused by applying too much torsional and lateral force which did lead to a mechanical overload during implantation.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "damaged wrench during the procedure in the placement of the screw, breaking the tip in the tightening of the screw.".

• Brand Name: SCREWDRIVER AXSOS T15 4.0MM LOCKING SET
• Common Device Name: SCREW, 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: 14592672
• Report Number: 0008031020-2022-00271
• Device Sequence Number: 5811010
• Product Code: HWC
• UDI-Device Identifier: 07613327005011
• UDI-Public: 07613327005011
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K141121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 702747
• Device Catalogue Number: 702747
• Device Lot Number: J21075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male