MAUDE Adverse Event Report: DEPUY MITEK MITEK DRILL PIN WITH EYELET .094X14; ACL DRILL BIT

Catalog Number 219321

Device Problem Device, or device fragments remain in patient (1527)

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

Event Date 06/05/2014

Event Type  Injury  

Event Description

Damaged device.In a cruciate ligament surgery, when placing the tip chast, this one broke in intra-articular in the knee.Piece of tip left in place.

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.In transit.

Manufacturer Narrative

The complaint device was received and evaluated.Visual inspection confirms the drill bit is broken at the proximal end of the drill's flutes.The shank part of the drill has multiple slip marks and scratches, indicating that the drill bit was in contact with another surface during the drilling action.Moreover, the shaft is slightly bent and twisted at two spots.The eyelet piece is bent, which might have contributed in the incorrect drill alignment.The broken distal end of the drill bit was examined under magnification and there is an indication that the failure was caused by twisting action during drilling.There is a metal burr at one side only at the breakage location.No further information was provided with the reported complaint.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Although, a batch number was not provided, a search by the product number was done from 2012-2014 and no other complaints from any lot were found.Without any information regarding the bone quality or how the reported incident took place, we cannot discern a root cause for this failure at this time; other than the possibilities mentioned above.At this point, no corrective action is required and no further action is warranted.However, depuy 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

Damaged device.In a cruciate ligament surgery, when placing the tip chast, this one broke in intra-articular in the knee.Piece of tip left in place.

• Brand Name: MITEK DRILL PIN WITH EYELET .094X14
• Type of Device: ACL DRILL BIT
• 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: 3935625
• MDR Text Key: 4536644
• Report Number: 1221934-2014-00301
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 219321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2014
• Date Manufacturer Received: 06/17/2014
• 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