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

Catalog Number 210712

Device Problem Break (1069)

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

Event Date 03/29/2024

Event Type  malfunction  

Event Description

It was reported from china that during a labral repair surgical procedure it was observed that the lupine br ds w/orthcrd anchor device was broken off.It was reported that all broken were removed from the patient.Another device was used to complete the procedure.There were no adverse consequences to the patient.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 mitek or its employees that the report constitutes an admission that the device, 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.E3: reporter is a j&j sales representative.Udi: (b)(4).Investigation summary: the product has not returned to depuy synthes mitek, however photos were provided for review.The photo investigation revealed that lupine br ds w/orthcrd was broken at the proximal end of the anchor.The suture and the anchor had foreign matter, presumably biological matter.No other anomalies could be observed.The overall complaint was confirmed as the observed condition of the lupine br ds w/orthcrd would contribute to the complained device issue.Based on the investigation findings, the potential cause can be traced to the procedural variables, such handling of the device or product interaction during procedure.As per instructions for use (ifu): do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• 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: 19079922
• MDR Text Key: 340689904
• Report Number: 1221934-2024-01140
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• 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 Catalogue Number: 210712
• Device Lot Number: 191L262
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1