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

Catalog Number 210712

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

This is report 1 of 2 for (b)(4).It was reported by the sales rep from china that before an unknown surgery, it was discovered that the packaging was opened, and it was discovered that the anchor on the lupine br ds w/orthcrd device had broken off.It was further reported that three others were opened, and they had the same issue.During in-house engineering evaluation, it was determined that the device had substance/debris/cleaning/sterilization and had fallen apart.Another device was used to complete the surgery.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

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.D10: concomitant med products and therapy dates: lupine br ds w/orthcrd device, (b)(6) 2024.E3: reporter is a j&j sales representative.Investigation summary: the product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned device.Visual inspection found that lupine br ds w/orthcrd suture and implant were detached from the inserter.The suture, anchor and inserter have foreign matter, presumably biological matter.No anomalies could be observed.The overall complaint was unconfirmed as the observed condition of the lupine br ds w/orthcrd would not contribute to the complained device issue.There was no non conformance regarding this lot.Based on the investigation findings, the potential cause for the suture condition is traced to the procedural variables, such handling of the device or product interaction during procedure.As per ifu, in handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.Excessive tension may overload the anchor or suture.As the device show signs of use, the reported complaint of failure without use cannot be confirmed, and 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 reported 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.Udi:(b)(4).

• 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: 19014778
• MDR Text Key: 339056721
• Report Number: 1221934-2024-01029
• 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
• Report Date: 04/01/2024

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 Expiration Date: 05/31/2024
• Device Catalogue Number: 210712
• Device Lot Number: 8L25420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2021
• 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