MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER, SELF-HOLDING, EXTRA SHORT 3.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060203
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
In a nail removal case, three screws were removed, and when the fourth screw was about to be removed, the screwdriver broke.The fourth screw was immediately removed using another screwdriver, and the operation proceeded without interruption.Before closing, surgeon confirmed that there were no metal fragments due to the broken screwdriver by c-arm and x-ray image.
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, since the product was returned broken as reported.The device inspection revealed the following: the returned screwdriver with the self-holding feature shows normal traces of use.The tip of the screwdriver is broken, the broken fragment was not returned.The breakage surface shows the typical structure of a brittle fracture (smooth surface, no plastic deformation) most likely due to a bending or torsional overload applied during use.It is worth noting that to prevent the bending, the device is laser-marked with do not lever.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 investigation, the root cause was attributed to an user-related issue.The breakage shows signs of torsional or bending overload applied on the screwdriver during use.As a reminder, the operative technique states that: it is recommended that the solid screwdriver be used for screw removal.The solid screwdriver applies greater torque and may reduce the potential for damaging the hexagonal tip on the screwdriver.Furthermore, the instructions for use also state that: avoid excessive workloads or wedging or twisting the instruments during the operation.In extreme cases this can lead to fracture of the instrument.Failure to observe this procedure can lead to fracture of the instrument and represents a high risk for the patient and the surgeon.In the course of the operation, repeatedly check that the connections required for precise positioning between the implant and instruments, or between the instruments themselves, are secure.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
In a nail removal case, three screws were removed, and when the fourth screw was about to be removed, the screwdriver broke.The fourth screw was immediately removed using another screwdriver, and the operation proceeded without interruption.Before closing, surgeon confirmed that there were no metal fragments due to the broken screwdriver by c-arm and x-ray image.

• Brand Name: SCREWDRIVER, SELF-HOLDING, EXTRA SHORT 3.5 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19860064
• Report Number: 0009610622-2024-00723
• Device Sequence Number: 20858646
• Product Code: LXH
• UDI-Device Identifier: 04546540520418
• UDI-Public: 04546540520418
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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 Catalogue Number: 18060203
• Device Lot Number: KMW351301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2014
• 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 Age: 48 YR
• Patient Sex: Female