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

Catalog Number	45-20001
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported."screwdriver tip broke off while tightening screw.11/14/2023 - update: ends with the screw head just slightly floating off the cortical bone.There is a damaged fragment that has not been found, so it is possible that it remains in the screw head.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported."screwdriver tip broke off while tightening screw.(b)(6) 2023 - update.Ends with the screw head just slightly floating off the cortical bone.There is a damaged fragment that has not been found, so it is possible that it remains in the screw head.".
Additional Manufacturer Narrative
Please note the correction to d9.The reported event could be confirmed based on the inspection performed.The device inspection revealed the following: the identification of the returned screwdriver was confirmed based on the catalog # and the lot # marked.The instrument is broken at its tip, the reported event could be confirmed.Microscopic images give indication of a sudden brittle fracture, as identified due to the regular and smooth surface of the breakage.The sudden breakage is most probably a result of excessive bending and/or torsional load during use.Material integrity inspection has shown the device to be within specification.Based on investigation, the root cause was attributed to an user related issue.The failure was most probably caused by excessive bending and/or torsional load applied to the screwdriver during screw implantation.A nc and capa were previously initiated in order to cover the recurring situation of breakage of asnis micro cannulated screwdriver blade 2.0mm tips and to improve its design.It must be highlighted, however, that the design change was implemented prior to the manufacturing of this lot.Therefore, the nc and the capa in question are not directly relevant for this complaint.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.If more information is provided, the case 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
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18241766
• Report Number: 0008031020-2023-00419
• Device Sequence Number: 7191169
• 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): 02/06/2024

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: 45-20001
• Device Lot Number: 1000433292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2021
• 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 Age: 50 YR
• Patient Sex: Male