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 Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available - pictures only.
Event or Problem Description
As reported: " the doctor was using a t20 screwdriver (703539) to remove a locking screw and replace it with a different length.The screw was tight, as the doctor applied more torque to the screwdriver, the tip of the blade snapped off.We recovered the broken piece and nothing additional remained in the patient.Additionally reported from sales rep, the actual item number for the screwdriver is (b)(4) with lot n00517.
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned for evaluation but a few pictures were shared which confirm the failure.The device was not received for evaluation, however a few pictures were shared which show the screwdriver broken from the tip region.It exhibited signs of forced fracture.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The above investigation has determined the failure mode related to this complaint was previously addressed by a design change in 2011: the blade of the screwdriver was shortened in order to increase its strength and consequently reduce the amount of breakages.The reported device was manufactured before the implementation of this change, therefore it has the old design.No further actions are required as of now.More information as well as the device must be available in order to determine the exact root cause of the failure.However, based on the event description and manner of breakage exhibited by the screwdriver, the most likely cause of the breakage would be due to a combination of bending and torsional overload.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: " the doctor was using a t20 screwdriver (703539) to remove a locking screw and replace it with a different length.The screw was tight, as the doctor applied more torque to the screwdriver, the tip of the blade snapped off.We recovered the broken piece and nothing additional remained in the patient.Additionally reported from sales rep, the actual item number for the screwdriver is 702748 with lot n00517.

• 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: 10399430
• Report Number: 0008031020-2020-02161
• Device Sequence Number: 3552851
• Product Code: LXH
• UDI-Device Identifier: 04546540713711
• UDI-Public: 04546540713711
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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: N00517
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1