MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702753
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the screwdriver tip was damaged during screw removal.The surgeon visually and radiographically confirmed that there was no remaining of the damaged material in the body.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the screwdriver tip was damaged during screw removal.The surgeon visually and radiographically confirmed that there was no remaining of the damaged material in the body.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned on (b)(6) 2022 for evaluation and matches the reported failure mode.The device inspection revealed the following: the received screwdriver bit shows signs of normal and prolonged usage however its tip is found to be broken.The breakage surface shows signs of slight rotational deformation/waves.Absence of plastic deformation and presence of an uneven breakage indicates that the breakage was instantaneous due to high torsional and bending overload.However, it cannot be excluded that residual stress from previous usage may have also contributed in the breakage.Due to the nature of the returned device, a functional inspection was not possible.The dimensional inspection of the returned screwdriver was done in which critical diameter was measured.The device was within specifications.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.Based on the above investigation, the root cause of the failure is user related.The breakage of the tip happened due to a combination of torsional and bending overload during the surgery.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.

• Brand Name: SCREWDRIVER BIT AXSOS T15, AO FITTING 4.0MM LOCKING SET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13289508
• Report Number: 0008031020-2022-00022
• Device Sequence Number: 4555518
• Product Code: LXH
• UDI-Device Identifier: 07613327005028
• UDI-Public: 07613327005028
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/29/2022

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: 702753
• Device Catalogue Number: 702753
• Device Lot Number: J03019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/24/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2016
• 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: Unknown