MAUDE Adverse Event Report: DEPUY MITEK RIGIDFIX PLA 3.3 MM FEMORAL ST CROSS PIN KIT; MITEK ACL IMPLANTS

Catalog Number 210133

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2014

Event Type  Injury  

Event Description

The sales rep reported that during an acl repair that the pin guides of customer's rigidfix st 3.3 cross pin kit and rigidfix st guideframe would bind together.The surgeon replaced the cross pin kit 2 times with the same issue.The sales rep reported that the guideframe was found to be warped and bent.The sales rep reported that no metal shavings were created.The surgeon completed the procedure with a 4th rigidfix st 3.3 cross pin kit and a second same type guideframe with no patient consequences.There was a 40 minute delay in the procedure.The sales rep could not provide the lot number or age for the guideframe but reported it has seen heavy use.See associated med watch 1221934-2014-00518, 1221934-2014-00520, 1221934-2014-00521.

Manufacturer Narrative

The complaint device is not being returned and therefore a physical evaluation cannot be performed.From the event details provided, the failure of the devices in this complaint could not be specifically determined and a root cause cannot be discerned.A batch record review has been conducted and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.Therefore, at this point in time, based on the complaint history, 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.

• Brand Name: RIGIDFIX PLA 3.3 MM FEMORAL ST CROSS PIN KIT
• Type of Device: MITEK ACL IMPLANTS
• 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: 4271388
• MDR Text Key: 5226825
• Report Number: 1221934-2014-00519
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: 210133
• Device Lot Number: 3784003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/28/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2014
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2014
• 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