MAUDE Adverse Event Report: I.T.S. GMBH CANCELLOUS STABILIZATION SCREW, D=3.0MM, L=16MM, RH

Model Number	37303-16
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have inspected the qc documents of the lot and the quality inspection forms as well as the material certificates showed no deviations and complies with the specifications.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.The angulation of the screw was aimed towards the proximal radial head and did not seem to exceed the 15 degree variable angle.But, the screw was already locked in the plate hole and the surgeon tried further and caused the head of the screw to crack.
Event or Problem Description
It was reported that the head of a locking screw cracked during final tightening.

• Brand Name: CANCELLOUS STABILIZATION SCREW, D=3.0MM, L=16MM, RH
• Common Device Name: CANCELLOUS STABILIZATION SCREW, D=3.0MM, L=16MM, RH
• 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; lassnitzhoehe, styria 8301 ; AU 8301
• MDR Report Key: 14494157
• Report Number: 3004369035-2022-00009
• Device Sequence Number: 20335765
• Product Code: HWC
• UDI-Device Identifier: 09120047295014
• UDI-Public: 09120047295014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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: 37303-16
• Device Catalogue Number: 37303-16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown