MAUDE Adverse Event Report: ARTHREX, INC. QUAD TENDON STRIPPER-CUTTER; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number	AR-2384
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/16/2017
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.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Device history record review revealed nothing relevant to this event.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.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 additional relevant information is received, a follow-up report will be submitted.Device requested but not yet received.
Event or Problem Description
It was reported that during an acl case, the surgeon tried to cut the quad tendon multiple times with the ar-2384, quad tendon stripper-cutter.The surgeon extended the incision and used scissors to cut the tendon.When the case was completed the sales rep inspected the device and found the weld where the shaft meets the handle was not intact.
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 device met all material specifications as received.The evaluation revealed broken/ insufficient weld at the point where shaft meets handle.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 additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during an acl case, the surgeon tried to cut the quad tendon multiple times with the ar-2384, quad tendon stripper-cutter.The surgeon extended the incision and used scissors to cut the tendon.When the case was completed the sales rep inspected the device and found the weld where the shaft meets the handle was not intact.

• Brand Name: QUAD TENDON STRIPPER-CUTTER
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6629190
• Report Number: 1220246-2017-00201
• Device Sequence Number: 849453
• Product Code: MDM
• UDI-Device Identifier: 00888867098244
• UDI-Public: 00888867098244
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 08/29/2017

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 Catalogue Number: AR-2384
• Device Lot Number: 011637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2017
• Supplement Date Received by Manufacturer: 05/16/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 08/28/2017
• 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