MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER, SELF-HOLDING, SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060238
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
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: "the upper part of the screwdriver is broken off.".
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed, since the device was not returned and no additional information was available.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text: device disposition unknown.
Event or Problem Description
As reported: "the upper part of the screwdriver is broken off.".
Additional Manufacturer Narrative
Please note correction to sections d9/h3, the device was returned, and h6 ( method, results and conclusion codes).The reported event could be confirmed, since the device was returned and matches the alleged failure.The received screwdriver showed normal signs of usage evident by the presence of scratch marks and normal wear.The blade is broken at the distal end and the small fragment was not returned.We can also see slight deformation on the hexagon.The breakage is in a brittle manner as there are no signs of plastic deformation.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.The appearance of the breakage surface indicates a (forced) brittle breakage of the screwdriver due to overload, most likely by bending stresses where it is mentioned that ¿do not lever¿.Generally, stryker osteosynthesis does not define the maximum number of uses for re-usable medical devices.Based on the above facts the root cause of the reported event is related to inadequate handling by the user.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the upper part of the screwdriver is broken off.".

• Brand Name: SCREWDRIVER, SELF-HOLDING, SHORT SCREWDRIVER, SELF-HOLDING 3.5 MM
• 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: 17393972
• Report Number: 0009610622-2023-00267
• Device Sequence Number: 14965881
• Product Code: LXH
• UDI-Device Identifier: 04546540520432
• UDI-Public: 04546540520432
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2024

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: 18060238
• Device Lot Number: KMW350801
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 01/31/2024
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/14/2023; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2007
• 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