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	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/10/2019
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 requested/is expected but has 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 that the bonecutter, ar-8550bc, was being used during aclr preparation when metal shards appeared.Additional information provided on 7/26/19: notchplasty was the surgical technique being performed when the issue occurred.The majority of the metal fragments were removed via suction.
Additional 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.Material analysis confirmed the ar-8550bc met all as-received specifications.

• 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: 8845631
• Report Number: 1220246-2019-01221
• Device Sequence Number: 13929162
• Product Code: GFA
• UDI-Device Identifier: 00888867043930
• UDI-Public: 00888867043930
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• 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: 03/31/2024
• Device Model Number: BONE CUTTER,5.5MM X 13CM
• Device Catalogue Number: AR-8550BC
• Device Lot Number: 10302488
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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