MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE BR DS W/ORTHCRD; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 210712

Device Problems Break (1069); Device Damaged Prior to Use (2284); Device Contaminated During Manufacture or Shipping (2969); Material Deformation (2976)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

It was reported by a healthcare professional in china that during an unknown arthroscopic procedure on (b)(6) 2023, it was observed that the anchor on 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 device was returned in used condition, the anchor was not returned, the shaft showed foreign material, presumably biological matter, the shaft as well as the inserter did not show structural anomalies, the suture was completely out of the device, it was broken into two pieces.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.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.H10 additional narrative: udi: (b)(4).Investigation summary
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> the device was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection of the device, it was observed that the device was returned in used condition, the anchor was not returned, the shaft show foreign material, presumably biological matter, the shaft as well as the inserter do not shows structural anomalies, the suture was completely out of the device, it was broken into two pieces.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.Based on the condition in which the device was returned, this complaint cannot be confirmed and a root cause for the issue experienced by the customer cannot be established.A possible root cause for the broken suture, can be related to procedural variables, such handling of the device or product interaction during procedure.An excessive tension could have been applied to the suture and consequently cause its breakage.As per ifu: do not use excessive tension or overload the suture.Doing so can lead to bone breakage and subsequent device pullout, or suture breakage.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 BR DS W/ORTHCRD
• 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: 17611149
• MDR Text Key: 321823951
• Report Number: 1221934-2023-03153
• 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

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210712
• Device Lot Number: 9L60576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• 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