MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SCREWDRIVER SHAFT, COMPRESSION T2 HUMERUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0263
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
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
As reported: "the driver broke off at the base while turning the compression screw with a compression driver to apply compression to the fracture.At the point, compression was sufficient, so the procedure was finished as it was.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the screwdriver shaft is broken as described.The device inspection revealed the following: the visual inspection has shown that the screwdriver is broken apart at the narrowed part of the shaft, the fragment is still fixed in the upper coupling part of the screwdriver.The lateral view of the fracture face shows that the material was twisted in clock-wise direction before the shaft broke.The fracture face has the typical view of a ductile overload fracture, where the applied force causes first a permanent distortion of the material with subsequent fracture.The previously described deformation of the shaft does match to this fracture pattern.In general is the in the year 2015 manufactured device in a used condition, there are wear marks at the hexagon tip visible.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 applying too much force onto the screwdriver during the described turning of the compression screw.In this relation following statement of the t2 humeral nailing system operative technique can be pointed out: ¿the short tissue protection sleeve is removed and the compression screw is gently tightened utilizing the two-finger technique." if more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the driver broke off at the base while turning the compression screw with a compression driver to apply compression to the fracture.At the point, compression was sufficient, so the procedure was finished as it was.".

• Brand Name: SCREWDRIVER SHAFT, COMPRESSION T2 HUMERUS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 16730805
• Report Number: 0009610622-2023-00116
• Device Sequence Number: 17853397
• Product Code: LXH
• UDI-Device Identifier: 04546540196330
• UDI-Public: 04546540196330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: 1806-0263
• Device Catalogue Number: 18060263
• Device Lot Number: K08F3E3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2015
• 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