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	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: according to the information provided, it was reported that the patient indication is right knee medial collateral ligament injury.During the surgery of ligament repair,opened the packing(before use), noted the body of anchor was deformed.Opened the 2nd one, still face with this issue.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.The second device was returned and evaluated.The visual inspection revealed that the anchor was bent near the 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.Our results indicate that this batch of product was processed without any incident related to the reported problem, and therefore there is no internally assignable cause for the reported problem.The storage conditions of these devices are unknown, and it is possible that they were exposed to high temperatures probably during transportation/ storage/ trunk stock resulting in the anchors to bend.This product should be stored in a cool dry place (below 80°f or 26°c), away from moisture and direct heat per ifu-108805.There was no information provided regarding this condition.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.
Event or Problem Description
It was reported by the affiliate in china that during a ligament repair procedure on (b)(6) 2020 for the right knee medial collateral ligament injury, it was observed that the body of the lupine loop plus anchor w/oc device was deformed upon opening its package.During in-house engineering evaluation, it was determined that the device was bent in the middle section.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

• 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: 11171601
• Report Number: 1221934-2021-00105
• Device Sequence Number: 11454579
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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: 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: 01/13/2021
• Initial Report FDA Received Date: 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR