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

Model Number 210708

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

This is report 1 of 3 for (b)(4).It was reported by a healthcare professional in china that during a shoulder procedure on (b)(6) 2022, it was observed that the anchor on the lupine loop plus anchor w/orthocord device was broken upon opening its package.During in-house engineering evaluation of the photo provided by the customer, it was determined that the anchor was 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.Udi: (b)(4).Investigation summary: both photo and the actual device were received and evaluated.Upon visual inspection of the photo, it could be observed that the 3 anchors, only one was broken while the other 2 were bent.The sutures are tensioning from the anchor to the handle's groove.The shaft of the 3 devices have no structural anomalies.According with the visual inspection of the photo, this complaint can be confirmed.The possible root cause of this failure can be attributed to the devices were exposed to a temperature higher than the recommended while in stock.Temperatures over 21 degrees celsius and the pre-set tension on the sutures may lead to a bent/broken anchor.No further information has been provided to help in the determination of the root cause for this failure.As per ifu 108805 store in a cool dry place.The device was received and evaluated.Upon visual inspection, it could be observed that the anchor was bent, also the sutures were tensioning from the anchor to the handle's groove, the shaft had no structural anomalies.According with the visual inspection result, this complaint can be confirmed.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 anchor deformation has been analyzed by spectroscopy characterization scanning electron microscope (sem); the results showed plastic deformation in the anchor.The component of this device is polylactic acid (pla), if exposed to high temperature, its structure gets compromised as it tents to loose 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.These damages have typical characteristics of material exposed to temperatures higher than recommended, however this cannot be conclusively determined.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.As per ifu- 108805, store in a cool dry place.A manufacturing record evaluation was performed for the finished device lot number: 8l67275, and no non conformances were identified.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 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 PLUS ANCHOR W/ORTHOCORD
• 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: 15627436
• MDR Text Key: 304624803
• Report Number: 1221934-2022-03143
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001064
• UDI-Public: 10886705001064
• 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: 210708
• Device Catalogue Number: 210708
• Device Lot Number: 8L67275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2022
• Initial Date FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• 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