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 Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that there was a breakage of the screwdriver tip.All the debris was removed from the patient.
Event or Problem Description
It was reported that there was a breakage of the screwdriver tip.All the debris was removed from the patient.
Additional Manufacturer Narrative
The reported event was confirmed.The device inspection revealed the following: the visual inspection has shown that the tip of the screwdriver is broken off, no fragment was returned for evaluation.The breakage surface of the device shows relatively smooth surface without any great abrupt features.The shiny areas on the broken region and the absence of plastic deformation indicate that the breakage was instantaneous (brittle fracture) due to excessive torsional or bending load.Furthermore, a hardness test according to rockwell on the returned item as well as a dimensional inspection indicate that the device is in accordance to the values in the material and in the dimensional specifications.Based on the investigation, the root cause was attributed to an user related issue.The failure was probably caused by torsional or bending overload applied to the device during usage.As a reminder, the instructions for use state: "in the course of the operation, repeatedly check that the connections required for precise positioning between the implant and instruments, or between the instruments themselves, are secure.While rare, intra-operative fracture or breakage of instruments can occur.Instruments which have experienced excessive use or excessive force are susceptible to fracture.Instruments should be examined for wear or damage prior to surgery." 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: 14220252
• Report Number: 0008031020-2022-00213
• Device Sequence Number: 4212653
• 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): 08/17/2022

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: 1000340587
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2019
• 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: 17 YR
• Patient Sex: Male