MAUDE Adverse Event Report: I.T.S. GMBH PF SET SCREW, STANDARD, L=120MM, PPS

Model Number	1F0-7-120A-S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have inspected the dhf of the affected nail and set screw and the material certificate and the batch was processed through the normal manufacturing and inspection operations with no non-conformance's 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 fracture has not healed and the patient experienced a fall on his left (implanted) side.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 report includes 1 nail and 1 set screw and therefore this is report 2/2.
Event or Problem Description
It was reported that a pf nail and a set screw broke approx.15 months post-op due to a patient fall.

• Brand Name: PF SET SCREW, STANDARD, L=120MM, PPS
• Common Device Name: PF SET SCREW, STANDARD, L=120MM, PPS
• 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: 25688519
• Report Number: 3004369035-2026-00320
• Device Sequence Number: 4670631
• Product Code: HSB
• UDI-Device Identifier: 09120116978046
• UDI-Public: 09120116978046
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K233134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1F0-7-120A-S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown