MAUDE Adverse Event Report: STRYKER GMBH 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	45-20001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
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
As reported: "proximal fracture of the left humerus.The screwdriver broke during the operation, but the doctor didn't notice it.After the operation was completed, it was confirmed that the driver was broken when cleaning the instrument.The inside of the patient was examined, but no debris was found.".
Event or Problem Description
As reported: "proximal fracture of the left humerus.The screwdriver broke during the operation, but the doctor didn't notice it.After the operation was completed, it was confirmed that the driver was broken when cleaning the instrument.The inside of the patient was examined, but no debris was found.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The 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 relatively smooth surface without any great abrupt features; however, the breakage is slightly uneven.Absence of plastic deformation indicates that the breakage was instantaneous (brittle fracture) due to high torsional and bending overload.The critical diameter of the drill was observed to be 2.98mm as required against a range of 2.95mm ¿ 3.00mm.Similarly, the average hardness of the drill was observed to be 55.6 hrc as required against a range of 54.0 hrc ¿ 58.0 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 investigation, the root cause was attributed to be user related.The breakage was caused due to a combination of torsional and bending overload applied on the screwdriver during the surgery.If any additional information is provided, the investigation will be reassessed.

• Brand Name: 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11076751
• Report Number: 0008031020-2020-02604
• Device Sequence Number: 19586401
• Product Code: LXH
• UDI-Device Identifier: 04546540534385
• UDI-Public: 04546540534385
• 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): 02/17/2021

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: 45-20001
• Device Catalogue Number: 45-20001
• Device Lot Number: 1000388960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1