MAUDE Adverse Event Report: ARTHREX LOGISTIC CENTER ARTHREX BONE CUTTER,5.5MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number AR-8550BC

Device Problem Particulates (1451)

Patient Problem No Code Available (3191)

Event Date 10/17/2019

Event Type  malfunction  

Event Description

Dr.Was performing a left shoulder arthroscopic rotator cuff repair.Dr.Noticed that while using the arthrex 5.5 bone cutter shaver that "metal flakes" came off in the wound.The surgical technologist stated that the shaver was rubbing or sticking when she tried to manually rotate the blade while it was off the arthrex shaver handle.Dr.Said that he irrigated the wound.The lot # of the effected shaver has been removed from the stock, and a defective product report has been filed.

• Brand Name: ARTHREX BONE CUTTER,5.5MM X 13CM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX LOGISTIC CENTER; 14550 plantation road; fort myers FL 33912
• MDR Report Key: 9334796
• MDR Text Key: 166771074
• Report Number: 9334796
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/18/2019

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-8550BC
• Device Catalogue Number: AR-8550BC
• Device Lot Number: 1185054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Weight: 78