MAUDE Adverse Event Report: ARTHREX, INC. DRL/SCRW,DISTAL CLAV PLT,RT; ARTHROSCOPIC ACCESSORIES

Model Number DRL/SCRW,DISTAL CLAV PLT,RT

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

On 2/27/2024, it was reported by a facility representative via (b)(4) that an ar-2664r drill/screw guide, distal clavicle plate came back broken after a case.It was stated that the device had no issues when it went out for the case, and nothing was reported to the rep of any issues with the device during use.This was discovered after use, with no patient harm reported.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.

• Brand Name: DRL/SCRW,DISTAL CLAV PLT,RT
• Type of Device: ARTHROSCOPIC ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 18896192
• MDR Text Key: 337595378
• Report Number: 1220246-2024-01442
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867098411
• UDI-Public: 00888867098411
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/13/2024

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
• Device Operator: Health Professional
• Device Model Number: DRL/SCRW,DISTAL CLAV PLT,RT
• Device Catalogue Number: AR-2664R
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1