MAUDE Adverse Event Report: DEPUY MITEK MITEK FLEXIBLE GUIDEWIRE - CONICAL TIPS .062 X 16; ACL INSTRUMENTS

Catalog Number 211322

Device Problem Tip breakage (1638)

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

Event Date 03/06/2015

Event Type  Injury  

Event Description

During acl reconstruction on the left side, the surgeon used the device for inserting a profile interference screw 9x20 ((b)(4)) for tibia and 7x20 ((b)(4)) for femur and it was broken.The broken piece is in the femor.The surgeon did not notice the breakage of the device during the surgery even with x-ray image after the surgery.The broken piece is still in the patient¿s body.Although there was a surgical delay, the extended time has not been reported.The patient is now under observation.The backup device was used to complete the case.The following additional information was received from our affiliate via email on 5-27-2015; the event date was verified to be (b)(6) 2015.The device was new, not re-processed.It is unknown if the procedure was extended for over thirty minutes.

Manufacturer Narrative

The complaint device is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Therefore, we cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.However one possible root cause is the guidewire complaint device was placed in a location where the screw came in contact with it during insertion resulting in the breakage of the guidewire.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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.Should any additional event or patient information be received at some point in the future, this complaint file will be reopened at that time to document the information, and a follow-up report will be filed.

• Brand Name: MITEK FLEXIBLE GUIDEWIRE - CONICAL TIPS .062 X 16
• Type of Device: ACL INSTRUMENTS
• 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: david primmerman ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4850190
• MDR Text Key: 5871136
• Report Number: 1221934-2015-00833
• Device Sequence Number: 1
• Product Code: NBH
• 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,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/20/2015

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: 211322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/20/2015
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2015
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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