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 Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: "the tip of the screwdriver was chipped during the removal surgery after bone healing.The tip of the screwdriver was defeated by the strong force.On 12/16/2021 - additional information received: the tip of the screwdriver was not left in patient¿s body and the procedure could be completed successfully.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the tip of the screwdriver is broken off.The device inspection revealed the following: the visual inspection has shown that the tip of the received screwdriver is broken off, the fragment was returned for evaluation.The microscopic investigation has shown there is no indication of a plastic deformation before the breakage occurred.Absence of plastic deformation and presence of an uneven breakage indicates that the breakage was instantaneous due to high torsional and bending loads.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material 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 the extraction of a screw.In this relation following statement of the implant extraction set operative technique can be mentioned: [the development of locking plate technology has led to ¿cold welding¿ of screws to the plates.In this case, cutting tools for metal have to be used for the removal of the screws.In order to help protect the soft tissue from excessive heat and metal debris accumulation, irrigation and suction should be used in combination with cutting tools.] [original statement].If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported: "the tip of the screwdriver was chipped during the removal surgery after bone healing.The tip of the screwdriver was defeated by the strong force.12/16/2021 - additional information received: the tip of the screwdriver was not left in patient¿s body and the procedure could be completed successfully.".

• 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: 13067181
• Report Number: 0008031020-2021-00506
• Device Sequence Number: 14909030
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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: J03885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2016
• 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