MAUDE Adverse Event Report: DEPUY MITEK 7X15MM MILAGRO INTERFERENCE SCREW; MITEK ANCHOR IMPLANTS

Catalog Number 231811

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

The complaint device is not available for a physical evaluation and no further information is available regarding technique or the instruments used in the procedure to determine the root cause for this failure.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.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).

Event Description

It was reported that during arcr the device was not fixed properly at the first attempt to repair lhb.When the surgeon inserted it again, it went deep into a bone hole therefore he removed only the screw.He fixed lhb with an anchor to a different bone hole and successfully completed the procedure with a 20-minute delay using the backup device.The sales rep has provided the instruction of this device to the surgeon.

• Brand Name: 7X15MM MILAGRO INTERFERENCE SCREW
• Type of Device: MITEK ANCHOR 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: 5707541
• MDR Text Key: 46854279
• Report Number: 1221934-2016-10232
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK120589
• 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
• Report Date: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• 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: 231811
• Device Lot Number: 3783835
• 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: 05/12/2016
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2014
• 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