MAUDE Adverse Event Report: DEPUY MITEK MITEK LUPINE LOOP PLUS ANCHOR WITH ORTHOCORD; ANCHOR IMPLANTS

Catalog Number 210708

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

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 06/25/2015

Event Type  Injury  

Event Description

During surgery the lupine suture anchors were used.Orthocord suture broke while putting the knot.The following additional information was received via email from our affiliate on 7-1-2015; only routine instruments which are used for shoulder arthroscopy were used in the procedure.Orthocord suture was broken on both anchors.The surgery was completed with a competitor¿s anchors.The procedure time was extended to nearly 1.30 hours because of the issue.See associated medwatch # 1221934-2015-00882.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to (b)(4) however it is not known if it will be received within the 30 day reporting requirement, therefore (b)(4) 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.In transit.

Manufacturer Narrative

Mitek received the complaint device and evaluated it visually.Two devices were reported for suture fraying, but only one set of sutures were received.It was observed from the received sample that the suture is frayed and broken, confirming this complaint.Based on the fraying on the suture, it is possible that an instrument used in the procedure caused this failure for example, if the instrument is used with a more abrasive suture than orthocord it may leave abrasions on the instrument, or if the instrument receives an impact on the distal tip, that also could leave a sharp edge on the instrument.Other than this possibility we cannot discern a root cause for this failure.A batch record review has been 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 of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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

During surgery the lupine suture anchors were used.Orthocord suture broke while putting the knot.The following additional information was received via email from our affiliate on (b)(6) 2015; only routine instruments which are used for shoulder arthroscopy were used in the procedure.Orthocord suture was broken on both anchors.The surgery was completed with a competitor's anchors.The procedure time was extended to nearly 1.30 hours because of the issue.See associated medwatch # 1221934-2015-00882.

• Brand Name: MITEK LUPINE LOOP PLUS ANCHOR WITH ORTHOCORD
• Type of Device: ANCHOR 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: bahaa nashed ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4939831
• MDR Text Key: 6192890
• Report Number: 1221934-2015-00881
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K062170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

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: 06/30/2017
• Device Catalogue Number: 210708
• Device Lot Number: 3790072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/25/2015
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2015
• Initial Date Manufacturer Received: 06/25/2015
• Initial Date FDA Received: 07/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2014
• 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