MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE LOOP PLUS ANCHOR W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 210708

Device Problems Bent (1059); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.¿ (b)(4).The expiration date is not currently available.

Event Description

Anchor found bend when open for surgery.

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate udi: (b)(4) incomplete.The expiration date is not currently available.

Event Description

Additional information received from affiliate on 18september2018: it was reported the issue was detected at the time of surgery.The surgery was not delayed and was completed successfully.It was noted alternatives were readily available and there was no impact to the patient.

Manufacturer Narrative

Correction: upon further review of the complaint, it was determined that the reported malfunction is unlikely to cause or contribute to serious injury or death if it were to recur.Therefore, this complaint is not reportable.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint devices were received and inspected.It was observed that each of the biocryl rapid anchor that was attached to the end of the inserter assembly was deformed.This complaint can be confirmed.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.(pending - our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed).One possible hypothesis for this type of failure would be exposure to high temperature during transportation/ stock/ trunk stock.High temperatures have been previously known to cause deformation of the biocryl anchors.Other than this consideration, we cannot discern a root cause for this failure.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution.No further information regarding the technique used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective and preventative 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).The expiration date is not currently available.

Event Description

Additional event information received on 10/17/2018.Account name : (b)(6).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number is not currently available.The complaint device was received and inspected.The complaint can be confirmed.It was observed that the anchor was deformed, and still attached to the device inserter via the tensioned suture cords.The device must be stored within a specific temperature range.The probable root cause of this failure is that the device was exposed to an elevated temperature before it was opened in the operating room prior to surgery.The elevated temperature and the slight tension on the suture could result in the bending of the anchor.In the manufacturing process there is a 100% verification in the assembly step for suture tension done by the operators.Then a sampling inspection of 13 units is done by a certified operator outside the production line.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, 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.Correction: it was inadvertently reported on the previous report that this complaint was not reportable.Upon complaint review, it was determined that this complaint is being filed as required under mitek's orrectiv aing filed as required under mitek's corrective and preventative actioons.Capa0 to file usa fda mdr missed malfunctions.Capa0 to file usa fda mdr missed malfunctions.D3, g1-2: manufacturer contact name, address, email address and phone number have been updated to reflect the correct information.

• Brand Name: LUPINE LOOP PLUS ANCHOR W/OC
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7634994
• MDR Text Key: 112302224
• Report Number: 1221934-2018-52377
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001064
• UDI-Public: 10886705001064
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210708
• Device Lot Number: 3906372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Date Manufacturer Received: 09/13/2019
• Patient Sequence Number: 1