MAUDE Adverse Event Report: ARTHREX, INC. MULTIFIRE SCORPION NEEDLE; MANUAL SURGICAL INSTRUMENT

Catalog Number AR-13995N

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/15/2017

Event Type  malfunction  

Event Description

While performing a rotator cuff repair (rcr), the arthrex scorpion multifire needle broke off inside the patient.

• Brand Name: MULTIFIRE SCORPION NEEDLE
• Type of Device: MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 6875 arthrex commerce drive; ave maria FL 34142
• MDR Report Key: 6653000
• MDR Text Key: 77930029
• Report Number: 6653000
• Device Sequence Number: 0
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: AR-13995N
• Device Lot Number: 10123532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 74