MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER AXSOS T20 5.0MM LOCKING SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702748
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
"the customer reported that during a femoral plating surgery, two screwdrivers broke intra op while attempting to extract a locking screw previously inserted to change his position.Additional information: the broken pieces were retrieved from the patient.The locking screw involved in the event has successfully been implanted.The surgeon did not applied pressure and did not worked at an extreme angle.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned and is indeed broken.The device inspection showed that both devices were returned with their tip broken.A microscope analysis shows a breakage due to torsional overload in both specimens.Indeed, torque lines can clearly be seen on the surface, allowing the conclusion that too much torsional force was applied to the screwdrivers during explantation of the screw.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by the application of an overtorque on the device.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 any further information is provided, the complaint report will be updated.
Event or Problem Description
"the customer reported that during a femoral plating surgery, two screwdrivers broke intra op while attempting to extract a locking screw previously inserted to change his position.Additional information: the broken pieces were retrieved from the patient.The locking screw involved in the event has successfully been implanted.The surgeon did not applied pressure and did not worked at an extreme angle.".

• Brand Name: SCREWDRIVER AXSOS T20 5.0MM LOCKING SET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11575723
• Report Number: 0008031020-2021-00105
• Device Sequence Number: 3599452
• Product Code: LXH
• UDI-Device Identifier: 04546540713711
• UDI-Public: 04546540713711
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 702748
• Device Catalogue Number: 702748
• Device Lot Number: L56805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1