MAUDE Adverse Event Report: DEPUY MITEK MILAGRO INTERFERENCE SCREW ABSORBABLE 8 X 30MM; MITEK ACL IMPLANTS

Catalog Number 231815

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 05/02/2016

Event Type  Injury  

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

During surgery, the screw left to the start if their introduction without there had been any misuse of the material.Additional information was received via email from the affiliate on 5-9-16.Type of procedure was acl reconstruction.Insertion was not off axis no.Patient did not have hard bone.The procedure was completed by opening another milagro advance interference screw.The original bone hole was used.An additional bone hole was not made to complete the procedure.The original anchor was removed from the patient.This failure did extend the procedure time greater than 30 minutes this device is coming back for evaluation.

Manufacturer Narrative

The complaint device is not available for a physical evaluation.Further information was provided regarding the device and technique used.However, a root cause for the reported failure cannot be determined.A batch record 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.

Event Description

Additional information received via email from the affiliate on 6-28-16.The screw broke on the tibial side.Screw driver for 30mm screw's was used to insert the screw.The screw was being inserted over a guidewire.Size of the tunnel on femoral and tibial was 7mm.The surgeon did not tap prior to inserting the screw- soft tissue (st) acl reconstruction.

• Brand Name: MILAGRO INTERFERENCE SCREW ABSORBABLE 8 X 30MM
• Type of Device: MITEK ACL IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808210
• MDR Report Key: 5688406
• MDR Text Key: 46184353
• Report Number: 1221934-2016-10221
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK060830
• 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: 05/02/2016

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: 01/31/2018
• Device Catalogue Number: 231815
• Device Lot Number: 3823095
• 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: 05/02/2016
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2015
• 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