MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, CURVED 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	EXCALIBUR, CURVED 4.0MM X 13CM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation confirmed the presence of horizontal grooves inferior to the cutting window of one of the returned ar-8400cex inner tubes.Similar grooves were also identified across the rear of the cutting window on the same device.These grooves were determined to be consistent with a site of metal debris production.The shrink tubing along both ar-8400cex devices were notably torn and rolled up along the inner tubes.This event is consistent with user applied mechanical force via prying/leveraging, as further evidenced by the presence of damage to the shrink tubing.Material analysis confirmed the ar-8400cex devices met all as-received specifications.
Event or Problem Description
It was reported that during a shoulder arthroscopy there was a strong abrasion of the metal.Also it was not possible anymore to attach the device onto the shaver handpiece cause the o-ring became loose.According to the surgeon there are no broken parts remaining inside the patient.The surgery was completed successfully with a new device of the same part number.There was no adverse event reported by the customer.Update 20-aug-2019: after contacting the surgeon to verify that there are no metal fragments remaining inside the patient, he could not confirm it.According to the surgeon there is a possibility that there are still metal abrasions inside the joint of the patient.

• Brand Name: EXCALIBUR, CURVED 4.0MM 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: 8980944
• Report Number: 1220246-2019-01306
• Device Sequence Number: 18923746
• Product Code: GFA
• UDI-Device Identifier: 00888867043503
• UDI-Public: 00888867043503
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: 12/31/2023
• Device Model Number: EXCALIBUR, CURVED 4.0MM X 13CM
• Device Catalogue Number: AR-8400CEX
• Device Lot Number: 10270631
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 09/10/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other