MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE VARIAX AO, T10, SELF RETAINING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703667
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will be returned therefore an evaluation of the device will be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It has been reported that the screwdriver blade was used for metal removal.Part of the blade has broken off.Replacement was available.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged event.The received device was visually inspected in we can see that the device is broken at the distal end into fragments and the fragment was not returned for inspection.With a microscopic view of the breakage, the surface indicates a brittle fracture as it is shiny and smooth in nature.The breakage is caused by the combined application of axial and rotational force.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.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 the investigation root cause can be attributed to user related as there are signs of application of high axial and rotational which was used during metal removal.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It has been reported that the screwdriver blade was used for metal removal.Part of the blade has broken off.Replacement was available.

• Brand Name: SCREWDRIVER BLADE VARIAX AO, T10, SELF RETAINING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19628202
• Report Number: 0008031020-2024-00257
• Device Sequence Number: 15587247
• Product Code: LXH
• UDI-Device Identifier: 04546540652393
• UDI-Public: 04546540652393
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2024

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: 703667
• Device Lot Number: 01791R
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2013
• 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 Sex: Unknown