MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE BR DS W/ORTHCRD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 210712

Device Problems Entrapment of Device (1212); Migration (4003)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4) incomplete.The expiration date is currently unavailable.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported by the sales rep that during a biceps tendinosis procedure on (b)(6) 2021, it was observed that the suture on the lupine br ds w/orthcrd device came out when the anchor was inserted.Another like device was used to complete the procedure with a ten minute delay.There were no adverse patient consequences 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 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.H10 additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 correction narrative: b1, b2: upon complaint review, it was determined that these fields were inadvertently missed on the previous report based on the additional information received regarding the event.Therefore, these fields have been updated accordingly to reflect the additional information regarding the event.

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.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the implants remained within the patient and were unable to be used for repair.It was further reported that the implants are within the bone and not doing anything.

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.H10 additional narrative: investigation summary : according to the information received, the lupine loop rapide anchor w/orthocord ds failed.Two of them has a crowded upper loop and the third anchor was inserted and the suture came out.Another device was used to complete the procedure.No patient consequences reported, 10 minutes surgical delay.These devices are implanted and not available to be returned, however the customer will return 4 new and unwanted devices from the same lot number.The device reported is still implanted in the patient; therefore, unavailable for a physical evaluation.One of the four returned devices was received for evaluation, mitek then conducted visual inspection of device.Visual analysis of the returned device, determined that the device was received in their original and sealed packaging.The package was open to review the condition of the device, as result, the lupine anchor was intact, it did not present any physical damage.A manufacturing record evaluation was performed for the finished device lot number:7l19038 , and no non-conformances related to the reported complaint condition were identified.Based on the information currently available this complaint cannot be confirmed.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, 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: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11446138
• MDR Text Key: 238669507
• Report Number: 1221934-2021-00774
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001101
• UDI-Public: 10886705001101
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 210712
• Device Catalogue Number: 210712
• Device Lot Number: 7L19038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 03/04/2021; 03/29/2021; 04/23/2021
• Supplement Dates FDA Received: 03/12/2021; 03/30/2021; 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention