MAUDE Adverse Event Report: ARTHREX, INC. PNCH, WB XL, 2.75 15U CV W/FLUSHPORT; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	PNCH, WB XL, 2.75 15U CV W/FLUSHPORT
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	11/19/2019
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 knee arthroscopy the arthrex device ar-11041xlf was used.The device produces metal abrasion.The metal abrasion is so thin and small that it was not possible to retrieve everything from the joint of the patient.The surgery was completed successfully with the complaint device.No further information received by the customer.
Additional Manufacturer Narrative
Could not duplicate complaint allegation.Material was inspected and could not confirm customer complaint.Material: ar-11041xlf/batch: 10291439 met both visual and cutting criteria during evaluation.

• Brand Name: PNCH, WB XL, 2.75 15U CV W/FLUSHPORT
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9440203
• Report Number: 1220246-2019-01463
• Device Sequence Number: 11315042
• Product Code: MDM
• UDI-Device Identifier: 00888867272842
• UDI-Public: 00888867272842
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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 Model Number: PNCH, WB XL, 2.75 15U CV W/FLUSHPORT
• Device Catalogue Number: AR-11041XLF
• Device Lot Number: 10291439
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other