MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER T20; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	703539
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A periprosthetic screw was properly inserted.The surgeon realized this particular screw was too long and wanted to remove it.During removal of the screw, three screwdrivers broke at the tip one after the other.The surgeon had to bore out the screwhead, remove the plate, over ream the screw shaft, remove the rest of the screw, and attach a new plate.There was a delay of approx.30 minutes.No debris was left in the patient.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Please note the correction to d4 lot #.The reported event could be confirmed, since the screwdriver is broken as complained.The device inspection revealed the following: the visual inspection has shown that the tip of the screwdriver is broken off, no fragments were returned for evaluation.Under the microscope it could be identified that the fracture face has the typical view of a brittle overload fracture with chevron marks and a shear lip on one side.The shear lip indicates that the device was exposed to high lateral forces when it broke.Based on that it can be concluded that a combination of high torsional and lateral forces during the screw extraction did lead to a mechanical overload.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.Related to the hardness it can be mentioned that the devices are hardened to withstand higher forces, this hardness explains why the device does rather break than get deformed.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 attributed to a user related issue.The failure was caused by the failure was caused by applying too much torsional and lateral force which did lead to a mechanical overload and finally the breakage of the device.In this relation the operative technique axsos 3 titanium monoaxial locking plate system can be mentioned: "final tightening of locking screws should always be performed manually using the torque limiter together with the screwdriver bit t20 and the t-handle.This helps prevent over-tightening of locking screws, and also ensures that these screws are tightened to a torque of 4.0nm.The device will click when the torque reaches the appropriate tightening torque." if more information is provided, the case will be reassessed.
Event or Problem Description
A periprosthetic screw was properly inserted.The surgeon realized this particular screw was too long and wanted to remove it.During removal of the screw three screwdrivers broke at the tip one after the other.The surgeon had to bore out the screwhead, remove the plate, over ream the screw shaft, remove the rest of the screw and attach a new plate.There was a delay of approx.30 minutes.No debris was left in the patient.

• Brand Name: SCREWDRIVER T20
• 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: 15335291
• Report Number: 0008031020-2022-00424
• Device Sequence Number: 6439203
• Product Code: LXH
• UDI-Device Identifier: 04546540693778
• UDI-Public: 04546540693778
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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: 703539
• Device Catalogue Number: 703539
• Device Lot Number: K05714C
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2019
• 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: 61 YR
• Patient Sex: Male