MAUDE Adverse Event Report: DEPUY MITEK LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS; MITEK ANCHOR IMPLANTS

Catalog Number 210712

Device Problems Bent (1059); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2017

Event Type  malfunction  

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 affiliate reported via email the device's top is bent when two packages were opened continuously.Enclosed please find the defect photos.Tried one of them to implant, it broke very easily when tapping during operation.Changed another one to complete.Additional info received from affiliate on 8-16-2017: the bent issue was found during open the package, and tried one bent device, it was found the device is very easy to break.The breakage of one anchor occurred during beginning of use.The broken fragment was removed by tool.The alternative anchor was readily available.Procedure was completed by changing to another one.

Manufacturer Narrative

The complaint devices were received and evaluated.Visual inspection confirms that one anchor is bent and one anchor is broken.A meeting was held with the engineer responsible for the product.It was determined that a manufacturing engineering action (mia) would be opened to review the manufacturing process used to assemble these devices.The mia investigated the dhr of the devices and the lot was released in accordance to established procedures.The lot of the anchors was also reviewed and no nonconformance¿s related to this complaint were opened against this lot.In the assembly process, there is a 100% verification in the assembly step done by the operators.A sampling inspection of 13 units is done by a certified operator outside the line.The fixtures used in the manufacturing of these devices have preventative maintenance performed every six months.Also, the operators were retrained on the assembly processes.Also, a capa has been opened to investigate the bioabsorbable anchor deformation.One possible root cause for the broken anchor is that as reported it was bent which could that could have caused the anchor to weaken and break during the procedure.This complaint can be confirmed.Based on the investigation we cannot determine what caused the anchors to bend.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.A review into the depuy synthes mitek complaints system revealed one other complaints 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.Udi: (b)(4).

• Brand Name: LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS
• 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: 6857095
• MDR Text Key: 86437274
• Report Number: 1221934-2017-10504
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150209
• 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: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 210712
• Device Lot Number: L179367
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2017
• Date Manufacturer Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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