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	09/28/2020
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: "the event occurred during the operation using aznis micro 2.0.The screwdriver tip was damaged when the screw was inserted without pre-drilling.The damaged driver was recovered.It is unknown whether there are other fine fragments, but when confirmed with a c-arm and x-ray, there was no fragments in the body.".
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 56.9 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.The event also suggested that pre-drilling wasn¿t performed, however the operative technique recommends pre-drilling, especially in case of hard bones.The device was manufactured prior to the capa taken to improve the strength of the screwdriver to increase its torque-to-failure (ttf) limit.Thus, no further action is required.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the event occurred during the operation using aznis micro 2.0.The screwdriver tip was damaged when the screw was inserted without pre-drilling.The damaged driver was recovered.It is unknown whether there are other fine fragments, but when confirmed with a c-arm and x-ray, there was no fragments in the body.".

• 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: 10726209
• Report Number: 0008031020-2020-02353
• Device Sequence Number: 13895191
• 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): 12/23/2020

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: 45-20001
• Device Catalogue Number: 45-20001
• Device Lot Number: AE05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1