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

Catalog Number	210708
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: mitek employee.Investigation summary: the complaint device was received and evaluated.Visual inspection of the returned device revealed the anchor was slightly bent mid-body, confirming this complaint.The anchor remained intact on the distal end of the inserter and the suture was intact within the handle at the proximal end of the inserter as intended.Exposure to high temperatures is known to contribute to this failure mode; however, it cannot be determined when or how this failure occurred.An mia (manufacturing investigation analysis) was initiated.The manufacturing process was performed according to the procedures and is not the root cause of this issue.The dhr review indicated that the 293 devices were processed with one nc unrelated to the reported incident.Furthermore, a complaint search in depuy synthes mitek complaints system revealed three similar complaints for this lot of 293 devices released to distribution.And at this 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.Device history lot dhr review.Part number: 210708.Supplier lot number: 3866730.Qty.:293.Release to warehouse date: november 13, 2015.Manufacturing date:november 13, 2015.Expiration date: september 30, 2018.Supplier: n/a.Manufacturing site: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition 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.
Event or Problem Description
It was reported by the sales rep that three of his lupine loop plus with orthocord were broke inside the package and being held together by the suture prior to a labral repair.Only one of the three anchors, the suture is off from the anchor, due to extreme deformity.The case was completed with two other like devices.There were no patient consequences or delays.The devices are being returned.This is report 2 of 3 for (b)(4).

• Brand Name: LUPINE LOOP PLUS ANCHOR W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9005905
• Report Number: 1221934-2019-58269
• Device Sequence Number: 16776515
• Product Code: MAI
• UDI-Device Identifier: 10886705001064
• UDI-Public: 10886705001064
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 210708
• Device Lot Number: 3866730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 09/12/2019
• Patient Sequence Number: 1