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

Model Number 37304-18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/20/2022

Event Type  malfunction  

Event Description

It was reported that locking screws didn't lock in a radius plate 3-hole.

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
• Type of Device: 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
• MDR Text Key: 307920301
• Report Number: 3004369035-2022-00165
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 09120047295113
• UDI-Public: 09120047295113
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K033756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other