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 Deformation (2976)

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

Event Date 01/17/2023

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.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, the anchor appears to be bent, it is out of its original packing.No further images were provided.A manufacturing record evaluation was performed for the finished device lot number: 9l60576, 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 result, this complaint can be confirmed.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more information to discern a possible root cause.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.

Event Description

This is report 1 of 3 for (b)(4).It was reported by a healthcare professional in china that preoperatively to an unknown procedure of the ankle, it was observed that the anchor on the lupine loop rapide anchor w/orthocord ds device was deformed.During in-house engineering evaluation of the photo provided by the customer, it was determined that the anchor appeared to be bent.Changed another two to continue the surgery, the same problem happened again.Another device was used to complete the surgery.There were no adverse consequences to the patient nor surgical delay reported.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.H10 additional narrative: investigation summary the device was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection of the device, the anchor was found bent, the shaft and the inserter tip do no show structural anomalies, the suture was found in good conditions and the handle as well.A manufacturing record evaluation was performed for the finished device lot number: 9l60576 and no non-conformances were identified.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.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.This type of defect in lupine anchors has been reviewed.The sample was characterized by scanning electron microscope (sem); as a result, the images show evidence of plastic deformation.When polylactic acid (pla), the component of this device, is exposed to temperatures over 21 degrees c, its structure gets compromised as it tents to lose mass, it provides flexibility to the polymer chains producing a decrease in the degree of crystallinity of the structure and the microhardness values causing these types of deformations (zuluaga, 2013).These damages have typical characteristics of material exposed to high temperatures; however, this cannot be conclusively determined.Please see the attachment isr-03142023-7192-2.Based on the results, the probable root cause of this failure is that the devices were 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.No further information regarding the cause of the defect has been provided to determine a root cause for this failure.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, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted 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: 16457215
• MDR Text Key: 310412758
• Report Number: 1221934-2023-00906
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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