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

Model Number 210712

Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)

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

Event Date 06/08/2022

Event Type  malfunction  

Event Description

It was reported by the customer in china that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the lupine loop rapide anchor w/orthocord ds device was deformed upon opening its package.During in-house engineering evaluation, it was determined that the anchor on the device was bent.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be 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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Investigation summary: 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 could be observed that the anchor is bent, also the sutures are tensioning from the anchor.The shaft has no structural anomalies.A manufacturing record evaluation was performed for the finished device 8l25692 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection of the photo, this complaint can be confirmed.The possible root cause can be attributed to the conditions of storage of the device.A combination of warmer temperature and tension can lead to a bent anchor.As per ifu: store in a cool dry place.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS
• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14944929
• MDR Text Key: 303935844
• Report Number: 1221934-2022-02045
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001101
• UDI-Public: 10886705001101
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 05/31/2024
• Device Model Number: 210712
• Device Catalogue Number: 210712
• Device Lot Number: 8L25692
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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