MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE LOOP PLUS ANCHOR W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	210708
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the lupine loop plus anchor w/oc device was deformed when opening its package.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
Additional 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.
Additional 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.Investigation summary: the complaint device has not been returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, it was observed that only one anchor and it 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 complaint reported was confirmed.A manufacturing record evaluation was performed for the finished device lot number 6l40998, and no non conformances were identified.Hands on analysis should provide the evidence necessary to confirm the root cause.The storage conditions of these devices are unknown.The component (polylactic acid (pla)) of this device, is exposed to temperatures over 21 degrees c, 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 temperatures higher than recommended, however this cannot be conclusively determined.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 ifu- 108805 store in a cool dry place.As part of depuy synthes mitek 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 mitkek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Device history lot: there were no non conformance regarding this lot.
Additional 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: 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.A manufacturing record evaluation was performed for the finished device lot number 6l40998, and no nonconformances were identified.A previously 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 (pla), the component of this device, is exposed to temperatures over 21 degrees c, 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 ifu: 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 mitkek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
Additional 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.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.

• Brand Name: LUPINE LOOP PLUS ANCHOR W/OC
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12919441
• Report Number: 1221934-2021-03561
• Device Sequence Number: 17540049
• Product Code: MAI
• UDI-Device Identifier: 10886705001064
• UDI-Public: 10886705001064
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/19/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 210708
• Device Catalogue Number: 210708
• Device Lot Number: 6L40998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 12/27/2021; 01/03/2022; 01/29/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/28/2021; 01/04/2022; 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown