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
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/01/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9506035
• Report Number: 1220246-2019-01507
• Device Sequence Number: 19333408
• Product Code: GFA
• UDI-Device Identifier: 00888867043930
• UDI-Public: 00888867043930
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 78