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

Model Number 210712

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).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 affiliate in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the anchor on the lupine br ds w/orthcrd device was deformed upon opening its package.Another like device was used to complete the surgery.There were no adverse patient consequences nor surgical delay reported.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 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.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.

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.Udi: (b)(4).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.No additional information was provided.Investigation summary: according to the information provided, it was reported that during the unknown surgery, opened the packing (did not use), noted the anchor was deformed (as the photo shows).Another device was used to complete the surgery.No additional information could be provided.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, it was observed that the anchor was bent near mid-body, confirming this complaint.The anchor remained intact on the distal end of the inserter and the suture was intact within the handle at the proximal end of the inserter as intended.The photo showed the same results found during the physical analysis.A manufacturing record evaluation was performed for the finished device lot number and no non conformances were identified.A manufacturing investigation was performed; as a result, there is a 100% control at different stages of production of: anchor tightening, by a torque meter + anchor/shaft assembly + anchor/shaft gap with a measuring gauge.Also, 100% visual control: check that no degradation on the suture and on the anchor is present.There has been a closer look on the in-process controls.The results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the document reviewed.The sample was characterized by scanning electron microscope (sem); as a result, the images show evidence of plastic deformation.When polylactic acid (play), the component 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 damages have typical characteristics of material exposed to high temperatures, 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.The elevated temperature and the slight tension on the suture could result in the bending of the anchor.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.As per the instructions for use, store in a cool 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, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history lot: there was no non conformance regarding this lot.

• 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
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12434110
• MDR Text Key: 270801059
• Report Number: 1221934-2021-02641
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2021

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: 05/31/2023
• Device Model Number: 210712
• Device Catalogue Number: 210712
• Device Lot Number: 7L06677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 09/29/2021; 12/23/2021
• Supplement Dates FDA Received: 09/30/2021; 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2020
• 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