MAUDE Adverse Event Report: ARTHREX INC. SUTURE CUTTER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	AR-4520
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned, therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a follow-up appointment from acl reconstruction, it was discovered that a piece of the distal tip of the instrument was lodged in the soft tissue.This was discovered during an x-ray.The patient was not complaining of pain.This was a male patient in mid to late 20s.The original surgery occurred on (b)(6) 2017.The broken device was not discovered in the or post-op.A revision surgery was scheduled for (b)(6) 2017 to remove the tip.Follow up investigation: during revision surgery the fragment was retrieved without complication.At this time the facility is not going to release the device to arthrex for evaluation.

• Brand Name: SUTURE CUTTER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6845941
• Report Number: 1220246-2017-00325
• Device Sequence Number: 1600096
• Product Code: LXH
• UDI-Device Identifier: 00888867033559
• UDI-Public: 00888867033559
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 09/08/2017

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: 04/01/2022
• Device Model Number: AR-4520
• Device Lot Number: 10136356
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/06/2017
• 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