MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO 25° RIGHT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	AR-6068-25R
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/28/2017
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/is expected for evaluation but has not yet been received.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not yet returned for evaluation 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.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that the surgeon used the suturelasso for the ramp lesion.During the procedure the tip of the lasso broke inside the patient and into the soft tissue.It took 1.5 hours for the surgeon to find and remove the broken tip.To find the broken tip he also did an x-ray.After that he changed the surgical technique and closed the rupture in the normal way with a needle and a suture.The surgery was a knee meniscus surgery.
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.This is a follow-up submission due to device evaluation.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that the distal tip was broken off.The device met all material specifications as received.The complainant's event is typically caused by leveraging against hard bone or another instrument.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that the surgeon used the suturelasso for the ramp lesion.During the procedure the tip of the lasso broke inside the patient and into the soft tissue.It took 1.5 hours for the surgeon to find and remove the broken tip.To find the broken tip he also did an x-ray.After that he changed the surgical technique and closed the rupture in the normal way with a needle and a suture.The surgery was a knee meniscus surgery.

• Brand Name: SUTURELASSO 25° RIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6724217
• Report Number: 1220246-2017-00275
• Device Sequence Number: 16291187
• Product Code: LXH
• UDI-Device Identifier: 00888867247512
• UDI-Public: 00888867247512
• 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: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2017

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: 09/01/2021
• Device Catalogue Number: AR-6068-25R
• Device Lot Number: 627167564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 07/21/2017
• 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