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)

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

Event Date 08/01/2023

Event Type  malfunction  

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: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, it was observed that the suture was not assembled in the shaft and the anchor was not received for evaluation; also, no anomalies were identified.Therefore, this complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot number: 125l207, and no nonconformances were identified.The anchor was not received for evaluation and no further information regarding the cause of the defect has been provided to help determine a root cause for this failure.If the component (poly (lactide[1]coglycolide) polymer and tricalcium phosphate (tcp)) 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.Based on the results, 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.An investigation with r&d was performed for further investigation; a possible root cause for this condition could be a combination of the elevated temperature and the slight tension on the suture could result in the bending of the anchor.Per further analysis, the risk level for visual: deformed/bent is an acceptable risk (ar) within risk management documents.Per ifu-109002, lupine br anchor system, ¿storage¿ section to store in a ¿cool and dry¿ place.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, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Event Description

This is report 1 of 2 for (b)(4).It was reported by the healthcare professional in china that during an shoulder scope procedure on (b)(4) 2023, it was observed that the anchor on the lupine loop rapide anchor w/orthocord ds device was broken off upon opening its package; and therefore, was not used.Changed to another one to continue the surgery but the same problem happened again.During in-house engineering evaluation, it was determined that the suture was not assembled in the shaft on the device.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• 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: 17729939
• MDR Text Key: 323192171
• Report Number: 1221934-2023-03387
• 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: 09/12/2023
• 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: 125L207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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