MAUDE Adverse Event Report: ARTHREX, INC. COOLCUT DISSECTOR, SJ; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number AR-7300DS

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

Patient Problem No Code Available (3191)

Event Date 04/05/2018

Event Type  malfunction  

Event Description

The head of a small (ankle scope) shaver blade broke off in the patient's ankle shortly after being inserted.Fifty-four (54) minutes of mini fluoroscopy and an additional incision to the posterior aspect of the patient's ankle were required to locate and remove the shaver head.

• Brand Name: COOLCUT DISSECTOR, SJ
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside blvd; naples FL 34108
• MDR Report Key: 7432186
• MDR Text Key: 105518177
• Report Number: 7432186
• Device Sequence Number: 1
• Product Code: HWE
• 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: 04/10/2018

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: 01/31/2022
• Device Catalogue Number: AR-7300DS
• Device Lot Number: 10122143
• Other Device ID Number: SJ 3.0MM X 7CM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2018
• 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: 18 YR