MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINELOOPPLUS ANCHOR W/OC DS; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 210709

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

It was reported by the healthcare professional in china that during a shoulder scope procedure on (b)(6) 2023, it was observed that the anchor on the lupine loop plus anchor w/orthocord ds device was deformed upon opening its package during in-house engineering evaluation, it was determined that the anchor was not received along with the device; but it was observed that the tip was deformed and the suture was not in the shaft.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay 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 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.Device was used for treatment, not diagnosis.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 photos and the complaint device were received and evaluated.Photos were returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photos.Upon visual inspection of the photos, the anchor was not attached and the tip was deformed.It was not possible to see the condition of the anchor.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, the anchor was not received along with the device.The tip was deformed and the suture was not in the shaft.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number: 116l561, 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 of the findings, this complaint cannot be confirmed, and a root cause of the issue reported cannot be determined.The condition of the inserter could be related to handling of the device.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.If the component (polylactic acid (pla) of this device is exposed to high temperatures, 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.These conditions have typical characteristics of material exposed to temperatures higher, however this cannot be conclusively determined.The possible root cause of the issue reported 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 bending the anchor.Per further analysis, the risk level for visual: deformed/bent is an acceptable risk (ar) within risk management documents.Per ifu- 108805, ¿storage¿ section to store in a ¿cool and 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: LUPINELOOPPLUS ANCHOR W/OC DS
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 17730908
• MDR Text Key: 323205731
• Report Number: 1221934-2023-03397
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001071
• UDI-Public: 10886705001071
• 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

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210709
• Device Lot Number: 116L561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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