MAUDE Adverse Event Report: I.T.S. GMBH TENSION BOLT, ULNA OSTEOTOMY PLATE

Model Number	680877
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a tension bolt broke intra-operatively.
Additional Manufacturer Narrative
We have inspected the dhf of the lot 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.Based on the information available and the performed failure analysis, no final conclusion could be drawn and 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.

• Brand Name: TENSION BOLT, ULNA OSTEOTOMY PLATE
• Common Device Name: TENSION BOLT, ULNA OSTEOTOMY PLATE
• 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: 18901663
• Report Number: 3004369035-2024-00002
• Device Sequence Number: 7886754
• Product Code: HWN
• UDI-Device Identifier: 09120069811742
• UDI-Public: 09120069811742
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K130008
• 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): 03/14/2024

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 Model Number: 680877
• Device Lot Number: 88/502554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Unknown