MAUDE Adverse Event Report: I.T.S. GMBH SCREWDRIVER, HANDLE 25MM, WS 2.5, L=120MM. CAN. 1.7MM

Model Number	56253-120
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of a screwdriver broke intraoperatively.
Additional Manufacturer Narrative
We have inspected the dhf of the affected lot including material certificate and the batch was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.The article met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The verification of the returned devices showed an oblique fracture surface of the hexhead of the screwdriver.Due to further investigation the cause could be traced to a violent fracture due to excessive physical force.Based on the information available, it has been determined that no corrective and preventative action is proposed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This report does not reflect a conclusion by fda, i.T.S.Gmbh or its employees that the report constitutes an admission that the device caused or contributed to the potential event described in this report.

• Brand Name: SCREWDRIVER, HANDLE 25MM, WS 2.5, L=120MM. CAN. 1.7MM
• Common Device Name: SCREWDRIVER, HANDLE 25MM, WS 2.5, L=120MM. CAN. 1.7MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzh[?]he, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzhöhe, styria 8301 ; AU 8301
• MDR Report Key: 18381871
• Report Number: 3004369035-2023-00015
• Device Sequence Number: 20733163
• Product Code: HXX
• UDI-Device Identifier: 09120034305894
• UDI-Public: 09120034305894
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: K060156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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: 56253-120
• Device Lot Number: 26/F63938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Unknown