MAUDE Adverse Event Report: ARTHREX, INC. 7.5 MM FLIP CUTTER II; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Catalog Number AR-1204AF-75

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 12/30/2014

Event Type  Injury  

Event Description

It was originally reported that the device was stuck in the bent position while inside the knee joint.Follow-up investigation: all inside acl-graftlink procedure.Surgeon was doing an all inside acl with the flipcutter.He had completed the femoral reaming and was about to do the tibial reaming with the 7.5 mm flipcuttter.He was able to drill with the flipcutter 3.5 mm drill pin size into the intra-articular space on the tibial side.He was able to flip the flipcutter to the 7.5 mm reaming size and was able to ream the 7.5 mm socket.After completion of the 7.5 mm socket, surgeon was unable to straighten the flipcutter to the 3.5 mm drill pin to remove the flipcutter.As a result, surgeon had to completely drill out a 7.5 mm through the cortical bone creating a 7.5 mm tunnel rather than a socket.A larger button was reported to be required to further fixate the graft.Device was discarded by facility and will not be returned.Further follow-up: the cutter on the right side became stuck so the only way to remove the device was to drill out a tunnel instead of making a socket as intended.The surgeon decided to use a button extender to make sure the graft remained tight and did not become lax or pull through the tunnel during healing.

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.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 returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.If the device is returned and additional information is obtained, a follow-up report will be submitted.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 was discarded by the facility.

Manufacturer Narrative

This follow-up is to correct the device part number from ar-1294af-75 to ar-1204af-75.Everything else stays the same.Device was discarded by the facility.

Event Description

It was originally reported that the device was stuck in the bent position while inside the knee joint.Follow-up investigation: all inside acl-graftlink procedure.Surgeon was doing an all inside acl with the flipcutter.He had completed the femoral reaming and was about to do the tibial reaming with the 7.5 mm flipcuttter.He was able to drill with the flipcutter 3.5 mm drill pin size into the intra-articular space on the tibial side.He was able to flip the flipcutter to the 7.5 mm reaming size and was able to ream the 7.5 mm socket.After completion of the 7.5 mm socket, surgeon was unable to straighten the flipcutter to the 3.5 mm drill pin to remove the flipcutter.As a result, surgeon had to completely drill out a 7.5 mm through the cortical bone creating a 7.5 mm tunnel rather than a socket.A larger button was reported to be required to further fixate the graft.Device was discarded by facility and will not be returned.Further follow-up: the cutter on the right side became stuck so the only way to remove the device was to drill out a tunnel instead of making a socket as intended.The surgeon decided to use a button extender to make sure the graft remained tight and did not become lax or pull through the tunnel during healing.

• Brand Name: 7.5 MM FLIP CUTTER II
• 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: 4625829
• MDR Text Key: 5760051
• Report Number: 1220246-2015-00067
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/26/2015

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 Expiration Date: 06/01/2019
• Device Catalogue Number: AR-1204AF-75
• Device Lot Number: 416048634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 03/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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