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	05/02/2022
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
It was reported that during a planned axsos plt extraction, the screw was extracted slightly by hand and then attempted to be extracted with an electric drill, but it was forwarded, causing the locking screw stuck to the plate.The subsequent attempt to remove it was too hard and the tips of two screwdrivers were broken.A t10 screwdriver prepared for other cases was used to remove, but also was broken.After that, extraction was completed using a carbide drill and crown drill.All debris was removed from the patient.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the device was received with a broken tip at the distal end.Only one part of the broken screwdriver is available for inspection.Microscopic views of the fracture surface show rotational deformation indicating forward application of high torsional load.The overall breakage pattern reveals brittle fracture most likely due to a combination of high torsional and bending load.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 the investigation, the root cause was finally attributed to a user-related issue.The failure was caused by applying too much torsional and bending force which did lead to a mechanical overload during the extraction of a screw.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that during a planned axsos plt extraction, the screw was extracted slightly by hand and then attempted to be extracted with an electric drill, but it was forwarded, causing the locking screw stuck to the plate.The subsequent attempt to remove it was too hard and the tips of two screwdrivers were broken.A t10 screwdriver prepared for other cases was used to remove, but also was broken.After that, extraction was completed using a carbide drill and crown drill.All debris was removed from the patient.

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14477105
• Report Number: 0008031020-2022-00266
• Device Sequence Number: 17476864
• 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): 08/05/2022

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: J03675
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2016
• 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