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

Model Number BONE CUTTER,5.5MM X 13CM

Device Problems Flaked (1246); Defective Device (2588)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/01/2019

Event Type  Injury  

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 via fda medwatch report (3600840000-2019-8018) that during a complete rotator cuff repair of the left shoulder in (b)(6) 2019, the 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 number of the effected shaver has been removed from the stock and a defective product report has been filed.The fda medwatch report received did not contain the specific date of the (b)(6) 2019 procedure.(b)(6) 2019 has been entered as the date of procedure until a specific date can be obtained.

Manufacturer Narrative

New information made this no longer a reportable event.The original mdr was filed due to a report that device fragments were left in the patient.The actual date of the procedure was (b)(6) 2019.The facility risk manager has confirmed that all metal flakes were fully removed from the patient.

• Brand Name: BONE CUTTER,5.5MM X 13CM
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9506035
• MDR Text Key: 174318579
• Report Number: 1220246-2019-01507
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867043930
• UDI-Public: 00888867043930
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: BONE CUTTER,5.5MM X 13CM
• Device Catalogue Number: AR-8550BC
• Device Lot Number: 1185054
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 78