MAUDE Adverse Event Report: ARTHREX, INC. EXCALIBUR, CURVED, HL 4.2MM X 19CM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	EXCALIBUR, CURVED, HL 4.2MM X 19CM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/12/2019
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 surgery the arthrex device ar-6420cex was used.During the shaver process it was noticed that metal abrasions of the device came inside the joint.The surgeon tried to suction the abrasions but he can't confirm that there are no micro parts of the metal remaining inside the patient.No further information received from the customer.
Additional Manufacturer Narrative
Complaint confirmed.The returned curved excalibur ar-6420cex was visually inspected, showing horizontal marks/grooves on the di of the outer tube.This is consistent with a site of metal debris production.A most likely cause is excessive force or prying/leveraging the device during use, as further evidenced by damage to the proximal end of the shrink tubing.

• Brand Name: EXCALIBUR, CURVED, HL 4.2MM X 19CM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9141765
• Report Number: 1220246-2019-01339
• Device Sequence Number: 2739963
• Product Code: LXH
• UDI-Device Identifier: 00888867039209
• UDI-Public: 00888867039209
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: 05/31/2024
• Device Model Number: EXCALIBUR, CURVED, HL 4.2MM X 19CM
• Device Catalogue Number: AR-6420CEX
• Device Lot Number: 10321067
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other