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

Model Number DRL,SCRW GD,DISTAL CLAV PLT

Device Problem Break (1069)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported that during a surgery the fixing screw broke during drilling.There was no harm for patient, operator or third party reported.No further information received.Update avoe 26-feb-2024.Further information was provided that the device failure occurred during an open reduction internal fixation (orif) surgery and all fragments were retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

The complaint is confirmed based on the customer-provided photo, which displays that the threaded rod, dowel pin, and hexalobe cap had been broken/disassembled.Also, it was noted that the locator pin is missing from the device.No batch number was provided.Per dfu-0023-eo at section i 1.Users of this device are encouraged to contact their arthrex representatives if, in their professional judgment, they require a more comprehensive surgical technique or more information.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.2.To avoid damaging the instruments, do not impact or subject to blunt force any instruments that are designed to be turned or screwed in.When two devices are intended to be threaded together, ensure that they are fully engaged prior to use.3.Do not use arthrex instruments for any purpose other than their intended use.Manipulating soft tissue or bone with an instrument not intended for that use may result in damage to the instrument.4.Instruments with adjustable components must be handled with care.Overtightening or rough handling of the instrument may damage the locking mechanism.Locking mechanisms with internal polymer components may become weakened after repeated autoclaving.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing the screw when inserting into the plate and/or hard bone.No change in harm was identified.

• Brand Name: DRL,SCRW GD,DISTAL CLAV PLT
• 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: 18876296
• MDR Text Key: 337459086
• Report Number: 1220246-2024-01404
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867098404
• UDI-Public: 00888867098404
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/11/2024

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 GD,DISTAL CLAV PLT
• Device Catalogue Number: AR-2664L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/11/2024
• 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