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

Catalog Number AR-2384

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem Tissue Damage (2104)

Event Date 01/09/2015

Event Type  Injury  

Event Description

It was reported that while trying to cut the quad tendon, the harvester got stuck and wouldn't release from the tendon.Surgeon could not release the harvester and had to make a second incision to cut the quad and remove the harvester.

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 received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.Complaint evaluation revealed the handle mechanism of the device does not work properly causing the cutter blade to not travel full distance.This complaint is still under investigation.At the current time the cause of the event cannot be determined.If additional relevant information is obtained from the investigation, a follow-up report will be submitted.

• Brand Name: QUAD TENDON STRIPPER- CUTTER
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4474691
• MDR Text Key: 5503690
• Report Number: 1220246-2015-00008
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/14/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: AR-2384
• Device Lot Number: 021426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other