MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX®; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number AR-13995N-1

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/05/2019

Event Type  malfunction  

Event Description

During rotator cuff repair, the tip of an arthrex multifire scorpion needle broke off inside the patient.A small piece could not be retrieved.The needle piece is embedded in the patient's tissue and cannot be felt or seen on x-ray.

• Brand Name: ARTHREX®
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8543594
• MDR Text Key: 142914585
• Report Number: 8543594
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2019

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: AR-13995N-1
• Device Catalogue Number: AR-13995N-1
• Device Lot Number: 10273169
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25550 DA
• Patient Weight: 111