MAUDE Adverse Event Report: I.T.S. GMBH CORTICAL STABILIZATION SCREW, D=3.0MM, L=18MM, RH

Model Number	37304-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that locking screws didn't lock in a radius plate 3-hole.
Additional Manufacturer Narrative
We have inspected the dhf of the affected lots 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 no deviations.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.

• Brand Name: CORTICAL STABILIZATION SCREW, D=3.0MM, L=18MM, RH
• Common Device Name: CORTICAL STABILIZATION SCREW, D=3.0MM, L=18MM, 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; lassnitzh[?]he, styria 8301 ; AU 8301
• MDR Report Key: 15915712
• Report Number: 3004369035-2022-00165
• Device Sequence Number: 20473861
• Product Code: HWC
• UDI-Device Identifier: 09120047295113
• UDI-Public: 09120047295113
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K033756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 12/05/2022

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: 37304-18
• Device Catalogue Number: 37304-18
• Device Lot Number: 86/435590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown