MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, 3.8MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	EXCALIBUR, 3.8MM X 13CM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/26/2019
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 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 during a procedure, the excalibur blade, ar-8380ex, was connected to the handpiece and inserted into the joint as normal.The surgeon activated the shaver in osc mode (without making contact with any soft tissue or bone and metals shards appeared).The metal fragments fell into the patient's body.Another blade was opened to complete the procedure.Additional information requested.Additional information provided 7/5/19: this occurred during tissue debridement during an ankle arthroscopy.Suction was used to remove metals shavings.Rep is not 100% certain that all fragments were removed.
Additional Manufacturer Narrative
The complaint could not be confirmed.No evidence of sites of metal debris production were observed on any of the three returned ar-8380ex excalibur devices.Material analysis showed the returned ar-8380ex devices met all as-received specifications.

• Brand Name: EXCALIBUR, 3.8MM 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: 8817445
• Report Number: 1220246-2019-01213
• Device Sequence Number: 14267454
• Product Code: GFA
• UDI-Device Identifier: 00888867043381
• UDI-Public: 00888867043381
• 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: 12/31/2023
• Device Model Number: EXCALIBUR, 3.8MM X 13CM
• Device Catalogue Number: AR-8380EX
• Device Lot Number: 10268840
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/23/2019
• 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