MAUDE Adverse Event Report: I.T.S. GMBH CANCELLOUS SCREW, CANNULATED, D=4.0MM, L=70MM

Model Number	31404-70
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have inspected the dhf of the affected screws and the 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.A definitive root cause could not be established following a technical investigation of the device and a clinical follow-up with the operating surgeon regarding the circumstances of the event.Based on the information available it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.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.This is report 2 of 2.
Event or Problem Description
It was reported that the distal thread end of two cannulated screws had stripped during insertion.

• Brand Name: CANCELLOUS SCREW, CANNULATED, D=4.0MM, L=70MM
• Common Device Name: CANCELLOUS SCREW, CANNULATED, D=4.0MM, L=70MM
• Manufacturer (Section D): I.T.S. GMBH; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• Manufacturer (Section G): I.T.S. GMBH; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• Manufacturer Contact: florian grill ; autal 28; lassnitzhoehe, styria 8301 ; AU 8301
• MDR Report Key: 24813252
• Report Number: 3004369035-2026-00102
• Device Sequence Number: 15874702
• Product Code: HWC
• UDI-Device Identifier: 09120034306112
• UDI-Public: 09120034306112
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: 31404-70
• Device Catalogue Number: 31404-70
• Device Lot Number: 679/012301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG