MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CANCELLOUS; PLATE, FIXATION, BONE

Model Number SCREW, CANCELLOUS

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Date 03/12/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported, that during a distal tibial osteotomy, after the ar-13715-09.0, hto plate was seated, as the surgeon was inserting the ar-13280-40, screw, it was noticed that the bushing on the plate came loose.The surgeon removed the plate and screw, the bushing was attached to the screw.The case was completed using ar-13100.09.There was 30-45 minutes added to the procedure requiring additional anesthesia.

Manufacturer Narrative

Complaint confirmed, the bushing was found disassembled, however no abnormality was observed on the screw that may have contributed to the event.

• Brand Name: SCREW, CANCELLOUS
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11648284
• MDR Text Key: 246852624
• Report Number: 1220246-2021-02881
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867010543
• UDI-Public: 00888867010543
• Combination Product (y/n): N
• PMA/PMN Number: K032187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SCREW, CANCELLOUS
• Device Catalogue Number: AR-13280-40
• Device Lot Number: 11381699
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other