MAUDE Adverse Event Report: DEPUY MITEK RIGIDFIX PLA 2.7 MM BTB CROSS PIN KIT; MITEK ACL IMPLANTS

Catalog Number 210127

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

Patient Problem Allergic reaction (1701)

Event Date 04/14/2014

Event Type  Injury  

Event Description

The sales rep reported that post op of an acl repair that was completed on (b)(6) 2014 that the patient developed hives all over their body and an allergic reaction.The sales rep did not have a timeframe of when the reaction began but reported it began shortly after the procedure in (b)(6).The sales rep stated that this repair was completed with no patient consequences or delay.The procedure was done with the milagro interference screw, 8 x 23mm and the rigidfix btb 2.7 mm cross pin kit.The sales rep reported that the patient has been to a dermatologist and has had numerous tests that have all come back negative.The sales rep reported that the patient had hard an acl repair in 2011 using the exact same devices with no issues or reaction.The sales rep did not know at this time if or when a revision would be completed.The sales rep was contacted to provide the material composition of the implants for further testing.The sales rep did not have any information regarding any treatments the patient may have undergone.See associated medwatch 1221934-2014-00517.

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.

Manufacturer Narrative

The complaint device has not been returned and no further information has been provided till date that would help in the investigation.A batch record review has been conducted and the results indicate that this batch of product was processed without any 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.From the complaint history, it seems that this failure is an anomaly and an isolated incident.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.

Event Description

The sales rep reported that post op of an acl repair that was completed on (b)(6) 2014 that the patient developed hives all over their body and an allergic reaction.The sales rep did not have a timeframe of when the reaction began but reported it began shortly after the procedure in april.The sales rep stated that this repair was completed with no patient consequences or delay.The procedure was done with the milagro interference screw, 8 x 23mm and the rigidfix btb 2.7 mm cross pin kit.The sales rep reported that the patient has been to a dermatologist and has had numerous tests that have all come back negative.The sales rep reported that the patient had hard an acl repair in 2011 using the exact same devices with no issues or reaction.The sales rep did not know at this time if or when a revision would be completed.The sales rep was contacted to provide the material composition of the implants for further testing.The sales rep did not have any information regarding any treatments the patient may have undergone.See associated medwatch 1221934-2014-00517.

• Brand Name: RIGIDFIX PLA 2.7 MM BTB 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: 4271357
• MDR Text Key: 5298370
• Report Number: 1221934-2014-00516
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013781
• 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,Followup
• 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: 12/31/2016
• Device Catalogue Number: 210127
• Device Lot Number: 3748818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/28/2014
• Device Age: 9 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: 01/21/2014
• 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): Required Intervention