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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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.Initial reporter phone number: (b)(4).Udi: (b)(4).
Event or Problem Description
It was reported that the patient indication is left knee medial collateral ligament injury.During the surgery of ligament repair, when implanting the anchor, the body of anchor was broken off.All the pieces were removed from the patient.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
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.D10, 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.
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: according to the information provided, it was reported that the patient indication is left knee medial collateral ligament injury.During the surgery of ligament repair, when implanting the anchor, the body of anchor was broken off.All the pieces were removed from the patient.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.The device was received and evaluated.It was observed that the end of the anchor was broken near the suture.Also, the suture was frayed.No more information regarding the procedure, thus we cannot discern a specific root cause.The possible root cause can be related when a excessive force on the distal end of the anchor due to levering during insertion.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.A manufacturing record evaluation was performed for the finished device lot number:6l43169, and no non-conformances were identified.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.

• 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
• MDR Report Key: 10653056
• Report Number: 1221934-2020-02924
• Device Sequence Number: 3316491
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2020

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: No Information
• Device Expiration Date: 10/31/2022
• Device Model Number: 210708
• Device Catalogue Number: 210708
• Device Lot Number: 6L43169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 11/20/2020; 12/13/2020
• Initial Report FDA Received Date: 10/08/2020
• Supplement Report FDA Received Date: 11/23/2020; 12/14/2020
• Patient Sequence Number: 1
• Patient Age: 17 YR