MAUDE Adverse Event Report: DEPUY MITEK MICRO QUICKANCHOR PLUS PRELOADED WITH 3/0 ETHIBOND SUTURE AND V-4 NEEDLES; MITEK NON ABSORBABLE ANCHOR IMPLANTS

Catalog Number 212865

Device Problems Material Frayed (1262); Unknown (for use when the device problem is not known) (2204)

Patient Problems Surgical procedure, delayed (2565); No Information (3190)

Event Date 04/13/2015

Event Type  Injury  

Event Description

During the surgery, the threads ruptured successively even without applying force on them.The threads also were released from the anchors easily.The surgeon questioned the products validity and it was verified that they were within the expiration date.He used 6 products in the surgery and all presented problems.The surgeon reported that there was an increase in the surgery time due to the problems occurred with the products.He didn¿t feel confident if the devices would have a good performance once they failed many times during the procedure.Associated medwatch # 1221934-2015-00781, 1221934-2015-00782, 1221934-2015-00783.

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

This follow-up is to document two addtional medwatch reference numbers.

Event Description

Associated medwatch # 1221934-2015-00781, 1221934-2015-00782, 1221934-2015-00783, 1221934-2015-00916, 1221934-2015-00917.

Manufacturer Narrative

The complaint device is not being returned, therefore unavailable for a physical evaluation.The reported condition could not be confirmed.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 1 other dissimilar complaint for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.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 the surgery, the threads ruptured successively even without applying force on them.The threads also were released from the anchors easily.The surgeon questioned the products validity and it was verified that they were within the expiration date.He used 6 products in the surgery and all presented problems.The surgeon reported that there was an increase in the surgery time due to the problems occurred with the products.He didn't feel confident if the devices would have a good performance once they failed many times during the procedure.Associated medwatch # 1221934-2015-00781, 1221934-2015-00782, 1221934-2015-00783.

• Brand Name: MICRO QUICKANCHOR PLUS PRELOADED WITH 3/0 ETHIBOND SUTURE AND V-4 NEEDLES
• Type of Device: MITEK NON ABSORBABLE 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: eric so ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4770930
• MDR Text Key: 5949696
• Report Number: 1221934-2015-00780
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K024115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor,company repres
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/13/2015

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: 10/31/2019
• Device Catalogue Number: 212865
• Device Lot Number: 3810487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/13/2015
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2015
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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