MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE, T7, AO; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	45-27015
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2022
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
As reported: "during a metal removal, 3 of 4 screwdrivers (45-27015) are broken at the tip.".
Additional Manufacturer Narrative
Please note the correction to h6 method code.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the device was received with a broken tip at the distal end.Only one part of the broken screwdriver is available for inspection.Microscopic views of the fracture surface show shiny points on the surface indicating the application of high torsional cyclic load.The overall breakage pattern reveals brittle fracture due to torque overloading of the blade.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 investigation, the root cause was attributed to a user-related issue.The failure was caused by applying too much torsional force which did lead to a mechanical overload during the extraction of a screw.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "during a metal removal, 3 of 4 screwdrivers (45-27015) are broken at the tip.".

• Brand Name: SCREWDRIVER BLADE, T7, AO
• 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: 16101168
• Report Number: 0008031020-2023-00005
• Device Sequence Number: 6228047
• Product Code: LXH
• UDI-Device Identifier: 04546540540423
• UDI-Public: 04546540540423
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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: 45-27015
• Device Catalogue Number: 45-27015
• Device Lot Number: AL03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2020
• 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 Sex: Unknown