MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE BR W/ORTHCRD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 210711

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information received, it was reported that during a shoulder instability surgery, the lupine loop rapide anchor w/orthocord was opened.After opening the sterile pack and the implant taken in sterile zone of or , before implanting the implant in patient, it was observed by the surgeon the lupine br anchor tip was damaged/broken.The surgeon did not raise any formal complaint but has raised question on the implant broken or damaged in sterile pack.Proper storage has been maintained for the implant.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it was observed that anchor was bent near 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.A manufacturing record evaluation was performed for the finished device lot number: 4l95794, and no non-conformances related to the reported complaint condition were identified.Hands on analysis should provide the evidence necessary to confirm the root cause.It is possible that they were exposed to high temperatures probably during transportation/ trunk stock resulting in the anchors to bend.This product should be in a cool dry place (below 80°f or 26°c), away from moisture and direct heat per ifu- 108180.There was no information provided regarding this condition.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of 198 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

It was reported by the sales rep in (b)(6) that during a bankart repair procedure for a shoulder instability, it was observed that the tip on the lupine loop rapide anchor w/ orthocord device was broken upon opening its sterile package and before implanting in the patient.During in-house engineering evaluation of the photo provided by the customer, it was determined that the device was bent near its mid-body.Another like device was used to complete the procedure with a 10 to 15 minutes of delay.There were no adverse patient consequences reported.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.H10 additional narrative: investigation summary = the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, it was observed that anchor was damage due to it was broken near mid-body, confirming this complaint.A manufacturing record evaluation was performed for the finished device lot number: 4l95794, and no non-conformances related to the reported complaint condition were identified.Based on the photo evidence and the physical analysis, it was possible that due to the manipulation and handling of the device it was found in this condition.The device could have been exposed to high temperatures probably during transportation/ trunk stock resulting in the anchors to bend and break.This product should be in a cool dry place, away from moisture and direct heat per ifu.There was no information provided regarding this condition.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.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.

• Brand Name: LUPINE BR W/ORTHCRD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12066840
• MDR Text Key: 258346547
• Report Number: 1221934-2021-01981
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001095
• UDI-Public: 10886705001095
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 210711
• Device Catalogue Number: 210711
• Device Lot Number: 4L95794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 01/11/2022; 01/26/2022
• Supplement Dates FDA Received: 01/12/2022; 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2019
• 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