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

Catalog Number 210133

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

The complaint device is not available for a physical evaluation.From the information provided, a root cause for this failure cannot be determined.Per mitek medical safety team¿s review, pla or biocryl will not have significant breakdown until approaching the 2 year mark.Six month fragmentation of the cross pins, which is not part of the breakdown process, most likely had some other cause leading to this issue.It cannot be determined whether the patient had another impact (while participating in sports) or it just occurred.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.However, a review into the depuy mitek complaints system revealed no similar complaints for this product code in the last 12 month.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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.(b)(4).Depuy synthes has been informed that the lot number is not available.Device not returned.

Event Description

(b)(6) 2015 patient suffered a knee injury during a soccer game, followed by physiotherapy (conservative approach).(b)(6) 2015 patient underwent surgery: replacement of anterior cruciate ligament using flexor tendons (semitendinosus) (also partially removing outer meniscus - menisectomy); the graft was fixated using rigidfix cross-pins.(b)(6) 2016 post op okay, healthy according to practitioner.(b)(6) 2016 patient returns to hospital, claiming he can¿t work.(b)(6) 2016 patient was informed of the requirement for a planned revision arthroscopy due to take place on the (b)(6) 2016.(b)(6) 2016 mri shows cruciate ligament replacement intact, but not with optimal tension, showing wavy course, the rigidfix cross-pins showed signs of fragmentation at 6 months after surgery.(b)(6) 2016 revision arthroscopy was not possible on this day, due to an infection of the lower jaw.(b)(6) 2016 patient underwent revision surgery: re-arthroscopy, scar revision removal in the area of the graft site.Post-op okay.According to surgeons, medical treatment/surgery was lege artis.Patient was informed well.Potential inappropriate weight burden/stress of joints could have led to cross-pin fragmentation.Cross-pin fragmentation was potentially influenced by infection of lower jaw.Reason for fragmentation of rigidfix pins is not due to user error.Additional information received via email from the affiliate on 11-4-2016 according the legal letter, the first surgery date was (b)(6) 2014, it was more than a year prior to the second surgery.

Manufacturer Narrative

The complaint device is not available for a physical evaluation.From the information provided, a root cause for this failure cannot be determined.Per mitek medical safety team¿s review, pla or biocryl will not have significant breakdown until approaching the 2-year mark.The 6-month fragmentation of the cross pins, which is not part of the breakdown process, most likely had some other cause leading to this issue.It cannot be determined whether the patient had another impact (while participating in sports) or it just occurred.A dhr review has been conducted and the results indicate that this batch of product was processed with an unrelated incident with no link to this complaint 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.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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.Udi: (b)(4).A follow up medwatch is being filed as new information was received on jan 10, 2017.Lot number, manufacture and expiration dates have been added.

• 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; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6134114
• MDR Text Key: 61084506
• Report Number: 1221934-2016-10511
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2016

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: 04/30/2018
• Device Catalogue Number: 210133
• Device Lot Number: 3842557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2016
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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