MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE LOOP O-C VIOLET *EA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222980
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: according to the information provided, it was reported that the 3 lupine suture anchors were broken (bent) right out of the box.The boxes were sealed and in excellent condition according to the nurse.3 other lupine anchors came out of the box with the suture loop disengaged from the mouth of the anchors.The complaint device was received and evaluated.Visual observations and visual inspection on the pictures provided confirm that 3 devices were observed that the anchors are bent, and 1 device was observed that was slight bent and the suture was disengaged from the mouth of the anchor.In addition, 1 device was received in its original packaging.The box presented marks of damage and was found stained, the sterility of the device was not compromised, because the inner package was in good conditions.The complaint reported was confirmed.The possible root cause for reported failure can be attributed to be exposure to high temperature during transportation/ stock/ trunk stock and for suture loop disengaged and for the damage in the box can be occurred during handling or transportation.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [4l53325] number, 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.Udi:(b)(4).
Event or Problem Description
It was reported by sales rep via distributor via complaint submission tool that 3 lupine suture anchors were broken (bent) right out of the box.The boxes were sealed and in excellent condition according to the nurse.3 other lupine anchors came out of the box with the suture loop disengaged from the mouth of the anchors.They are asking for a credit for these 6 anchors and a follow up report on why this occurred.There were no adverse consequences to the patient.There was a surgery delay of 5 minutes reported.The devices are available to be returned for evaluation.

• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10681094
• Report Number: 1221934-2020-03006
• Device Sequence Number: 2977432
• Product Code: MAI
• UDI-Device Identifier: 10886705008582
• UDI-Public: 10886705008582
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2020

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 222980
• Device Catalogue Number: 222980
• Device Lot Number: 4L53325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2020
• Initial Report FDA Received Date: 10/14/2020
• Patient Sequence Number: 1