MAUDE Adverse Event Report: STRYKER GMBH EXTRACTOR ASNIS III FOR SCREWS:4.0MM AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	702496
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
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
When pulling out the aznis 4.0 mm screw which was inserted in the tibial medial malleolus, the surgeon used an extractor (4.0mm in diameter).As the patient had good bone quality, it was difficult to remove, and the extractor broke during removal.After that, the surgeon used pliers owned by the hospital, and the procedure completed without problem.
Event or Problem Description
When pulling out the aznis 4.0 mm screw which was inserted in the tibial medial malleolus, the surgeon used an extractor (4.0mm in diameter).As the patient had good bone quality, it was difficult to remove and the extractor broke during removal.After that, the surgeon used pliers owned by the hospital, and the procedure completed without problem.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Device inspection revealed the following: the received extractor shows signs of normal and prolonged usage however its tip is found to be broken.The breakage surface shows a smooth surface for most part.Absence of plastic deformation indicates that the breakage was instantaneous due to high torsional and bending overload.However, it cannot be excluded that residual stress from previous usage also may have contributed in the breakage.The critical diameter of the drill was observed to be 2.56mm as required against a range of 2.50mm ¿ 2.60mm.Similarly, the average hardness of the drill was observed to be 54.2 hrc as required against a range of 53.0 hrc ¿ 57.0 hrc.As per the dimensional inspection and hardness testing, the returned drill was found to be within specifications.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.Based on the above investigation, the root cause of the failure is user related.The breakage of the tip happened due to a torsional and bending overload, the likelihood of which is greater during an explantation.If any further information is provided, the complaint report will be updated.

• Brand Name: EXTRACTOR ASNIS III FOR SCREWS:4.0MM AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10757213
• Report Number: 0008031020-2020-02363
• Device Sequence Number: 11578575
• Product Code: LXH
• UDI-Device Identifier: 04546540112415
• UDI-Public: 04546540112415
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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: 702496
• Device Catalogue Number: 702496
• Device Lot Number: 03676L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1