MAUDE Adverse Event Report: DEPUY MITEK VERSALOK ANCHOR WITH ORTHOCORD; MITEK ANCHOR IMPLANTS

Catalog Number 210818

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer 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

The sales rep reported that during a rotator cuff procedure once their versalok peek with orthocord was inserted the outer portion of the device stayed in but the inner portion pulled out.The sales rep stated that the surgeon left the outer portion in the patient.The sales rep reported that the surgeon completed the procedure by creating a new bone hole and using another like device with no patient consequences or delays.The sales rep stated that the bone quality of the patient was average.The sales rep stated that the inner portion will be returning for evaluation.

Manufacturer Narrative

Only the pin of the complaint device was returned to mitek and therefore a complete physical evaluation could not be performed.The reported failure of versalok anchor inner portion pull out cannot be confirmed.Visual inspection under magnification does not reveal any anomalies on the pin.The device was reviewed with the quality engineer for the product and the potential root cause of the failure could possibly be incorrect user technique during the insertion of the device.If the anchor was inserted at an off angle it could cause this failure.A batch review was conducted to determine if there were any internal processing issues, which would have contributed to the nature of the product complaint.Our results indicate that this batch was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no further actions are warranted.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).

• Brand Name: VERSALOK ANCHOR WITH ORTHOCORD
• Type of Device: MITEK ANCHOR 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: 5954191
• MDR Text Key: 54878078
• Report Number: 1221934-2016-10380
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2016

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: 02/28/2018
• Device Catalogue Number: 210818
• Device Lot Number: 3829007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2016
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2015
• 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