MAUDE Adverse Event Report: ARTHREX, INC. IMP SYS, TIGHTROPE RT W/10.0MM FLIP CUTTER II; PIN, FIXATION, SMOOTH

Catalog Number AR-1588RT-11

Device Problems Bent (1059); Break (1069); Detachment Of Device Component (1104); Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/09/2014

Event Type  Injury  

Event Description

It was originally reported that when using flip cutter, they pushed the button to change the pin to the cutter then started cutting and the wings broke off and the tip of the flip cutter blossomed out.It was stuck in the knee within the sheath.Took approximately 1 hour to be able to free the pieces and find them as well as to remove the flip cutter.Used a shaver, burr, needle driver and other pieces to remove the pieces.Other than metal shavings, all pieces were fully retrieved from patient.Once that was done, they used a 10.5 mm flip cutter to complete the case.No patient harm noted at this time.Acl reconstruction.Follow up to clarify event: as the cutter had come out of the sleeve and began to start cutting the bone, the tip began to flare out and bend around the sleeve.The deformed cutter could not pass back through the sleeve nor could the sleeve be removed.The surgeon then began to snip the flared pieces away from the device.Once that was done, the remaining pieces were burred down flat and both devices were removed.Another device was used in the same hole to complete the case.Follow-up information: during the patient's 2 week post-op visit, the surgeon performed a post-op x-ray, and found some of the fragments still in the patient behind his knee.The surgeon had also stated to the patient and family that he was not satisfied with the outcome of the case.He would like the patient to come in to revise the acl.The patient has not rescheduled the revision to date.

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.The evaluation revealed the cutting surfaces of the cutter are dull (drill mode) and the corners are rounded.The evaluation also revealed two sets of faint circular marks around the shaft of the actuator tube.Complainant's event typically caused by user mechanical damage to device such as hitting the device with another device, prying/leveraging or excessive bending forces being applied during use.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.

• Brand Name: IMP SYS, TIGHTROPE RT W/10.0MM FLIP CUTTER II
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 4184669
• MDR Text Key: 5025255
• Report Number: 1220246-2014-00195
• Device Sequence Number: 1
• Product Code: HTY
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/22/2014

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 Expiration Date: 05/01/2018
• Device Catalogue Number: AR-1588RT-11
• Device Lot Number: 771141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other