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 Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2019

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 that the arthrex bone cutter ar-8550bc was used during an acromioplasty surgery.During the milling mode the chip of the device broke off.It was not possible to remove the broken fragment.It will remain inside the patient.The surgery was completed successfully with the complaint device.No further information received at the moment.Arthrex gmbh will ask the customer what is meant by the chip of the device.Additional information obtained 03-dec-2019: according to the customer there were metal shavings seen and the will remain inside the patient.

Manufacturer Narrative

Complaint confirmed.Visual evaluation revealed the presence of horizontal grooves opposite of the cutting window across the ar-8550bc inner tube.Corresponding grooves were identified within the inner diameter of the outer tube window, and consistent with a site of metal debris production.This event is consistent with user applied mechanical force via prying/leveraging, as further evidenced by the presence of scuffing along the shrink tubing at the proximal end of the device.

• 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: 9443814
• MDR Text Key: 173454530
• Report Number: 1220246-2019-01468
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: BONE CUTTER,5.5MM X 13CM
• Device Catalogue Number: AR-8550BC
• Device Lot Number: 10378376
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 02/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other