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); Detachment of Device or Device Component (2907)

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

Event Date 04/27/2023

Event Type  malfunction  

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.H10 additional narrative: udi: (b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it was observed that the anchor was not in place, and it was not possible to see the condition.The inserter was fell out of the shaft.Based on the condition of the device, this complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 9l60576, and no nonconformances were identified.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more information to discern a possible root cause.This product has a 100% control at different stages of manufacturing line: anchor tightening, by a torque meter + anchor/shaft assembly + anchor/shaft gap with a measuring gauge.Also, 100% visual control: check that no degradation on the suture and on the anchor is present.The probable root cause of the damage on the inserter could be related when twist or apply excessive force to the inserter.As per ifu: do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip.Excessive tension may overload the anchor or suture.As part of mitek¿s 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, in depuy synthese mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

Event Description

It was reported by a healthcare professional in china that during a rotator cuff repair procedure on (b)(6) 2023, it was observed that the lupine loop rapide anchor w/orthocord ds device was deformed upon opening its package; and therefore, the device was not used.During in-house engineering evaluation of the photo that was received from the customer, it was determined that the inserter had fallen out of the shaft on the device.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• 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: 17078981
• MDR Text Key: 317660016
• Report Number: 1221934-2023-02316
• 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 Model Number: 210712
• Device Catalogue Number: 210712
• Device Lot Number: 9L60576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2023
• Initial Date FDA Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2022
• 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