MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BIT IMPLANT EXTRACTION SET T15; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18066119
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two screwdrivers were damaged in this set whilst being used in theatre.
Additional Manufacturer Narrative
Once the investigation has been completed.Any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
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 received screwdriver shows signs of normal usage however its tip is found to be broken.The breakage surface shows signs of slight rotational deformation/waves.Absence of plastic deformation indicates that the breakage was instantaneous due to high bending load and torsional overload.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.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 and lateral force which did lead to a mechanical overload during usage.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that two screwdrivers were damaged in this set whilst being used in theatre.Upon receipt of the devices, the tip was found to be broken.

• Brand Name: SCREWDRIVER BIT IMPLANT EXTRACTION SET T15
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17097617
• Report Number: 0009610622-2023-00196
• Device Sequence Number: 19306483
• Product Code: LXH
• UDI-Device Identifier: 07613154403851
• UDI-Public: 07613154403851
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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 Catalogue Number: 18066119
• Device Lot Number: KSS15D261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2015
• 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