MAUDE Adverse Event Report: DEPUY MITEK MITEK INTRAFIX TIBIAL SHEATH INSERTER, FIXED HANDLE; ARTHROSCOPIC INSTRUMENT

Catalog Number 254616

Device Problem Tip breakage (1638)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 06/27/2014

Event Type  Injury  

Event Description

Email from dr.(b)(6) stated an intrafix tibial sheath inserter broke off inside the tibia of a patient during an acl recontruction.Could not remove it and backed it up with a washer/post.Additional information: product code of the inserter: 254616.What size sheath inserter was it? 30mm.Was this biointrafix/regular intrafix? regular intrafix.What size tibial tunnel was drilled - 8mm.Date of the procedure - (b)(6) 2014.How was the procedure completed (what did you mean when you stated you "backed it up with a washer/post?" don't know how else to describe, except i used suspensory fixation with a partially threaded 6.5 mm cancellous screw and washer the graft ends were tied around it and the screw was advanced.This is a well described technique for tibial fixation.Did this failure extend the procedure time longer than 30 minutes? yes.Yes, the sheath is still in the patient.It was not prominent and i could not remove without destroying the graft so we left it in there.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.Awaiting return.

Manufacturer Narrative

The complaint device was received and evaluated.The inserter is snapped at the tip, confirming this complaint.The device also appears to be worn from heavy use.The product code 254616 is no longer an active code at mitek, this means the device is at least 5 years of age.Possible cause for this failure is the combination of heavy use/ age with off axis trialing.A batch review was not conducted as the batch number is unknown.At this point in time, no corrective action is required and no further action is warranted.However, mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Event Description

Email from dr.(b)(6) in (b)(6) stated an intrafix tibial sheath inserter broke off inside the tibia of a patient during an acl recontruction.Could not remove it and backed it up with a washer/post.Additional information: product code of the inserter: 254616.What size sheath inserter was it? 30mm.Was this biointrafix/regular intrafix? regular intrafix.What size tibial tunnel was drilled - 8mm.Date of the procedure - (b)(6) 2014.How was the procedure completed (what did you mean when you stated you "backed it up with a washer/post"? don't know how else to describe except i used suspensory fixation with a partially threaded 6.5 mm cancellous screw and washer the graft ends were tied around it and the screw was advanced.This is a well described technique for tibial fixation.Did this failure extend the procedure time longer than 30 minutes? yes.Yes, the sheath is still in the patient.It was not prominent and i could not remove without destroying the graft so we left it in there.

• Brand Name: MITEK INTRAFIX TIBIAL SHEATH INSERTER, FIXED HANDLE
• Type of Device: ARTHROSCOPIC INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4073718
• MDR Text Key: 16181731
• Report Number: 1221934-2014-00390
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 254616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/27/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2014
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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; Required Intervention