MAUDE Adverse Event Report: ARTHREX, INC. RETRACTABLE CANNULATED KNIFE, STRAIGHT; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	AR-6527-01
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device met material specifications as received.The evaluation revealed that the blades sheared-off.Additionally, nicks were observed on the sharp edges of blades.Device history record review revealed nothing relevant to this event.Complainant's event was most likely caused by user mechanical damage such as hitting the device with another device and the use of excessive bending force this is the (b)(4) complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a hip arthroscopy, labral repair and cam lesion debridement, the surgeon cut the hip labral and deployed the knife which broke in the patient during cutting.This happened twice with two devices from the same lot.These were both retrieved; the case was not completed.This was due to 45 minutes of traction time and extravasation in the abdomen.The surgery has been rescheduled in 30 days.Patient is female in her 20s.Additional information obtained 3/16/17: it was reported that patient was not kept overnight and was discharged same day.Extravasation was relieved with massage.Surgery has been rescheduled for monday, (b)(6).

• Brand Name: RETRACTABLE CANNULATED KNIFE, STRAIGHT
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6423726
• Report Number: 1220246-2017-00088
• Device Sequence Number: 455391
• Product Code: GFA
• UDI-Device Identifier: 10888867039879
• UDI-Public: 10888867039879
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2017

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: 11/01/2021
• Device Catalogue Number: AR-6527-01
• Device Lot Number: 10082104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other