MAUDE Adverse Event Report: ARTHREX, INC. BUR,RND,SJ,8 FLUT 3.0MMX 7CM; BURR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	BUR,RND,SJ,8 FLUT 3.0MMX 7CM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/12/2018
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 actual device used during the procedure was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a knee arthroscopy the shaver blade was spreading metal pieces in the patient's joint.According to the surgeon two metal pieces were grinding against each other and metal pieces spread all over the joint.It extended the surgery time because the surgeons had to spend time getting all the pieces out of the joint.The surgeon can't confirm that all the pieces are retrieved.A different shaver blade (part number unknown) was used to finish the surgery successfully.It was not necessary to switch the surgical technique or do a second surgery.Update 23 nov 2018: the surgery took 1 hour longer than "initialy" planned.We requested further information if all the fragments are retrieved but we did not get a 100% confirmation of this.Statement of the sales rep (arthrex dk): the surgeon was able to retrieve the metal pieces.I do not have an x-ray so we cannot be 100% sure that everything was retrieved.The facility discarded the device but will send in a unused device of the same batch for evaluation.

• Brand Name: BUR,RND,SJ,8 FLUT 3.0MMX 7CM
• Common Device Name: BURR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8155440
• Report Number: 1220246-2018-00793
• Device Sequence Number: 13520101
• Product Code: GFF
• UDI-Device Identifier: 00888867041967
• UDI-Public: 00888867041967
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2018

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 Model Number: BUR,RND,SJ,8 FLUT 3.0MMX 7CM
• Device Catalogue Number: AR-7300RBE
• Device Lot Number: 1303924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/12/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other