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 Deformation (2976)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (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.Multiple attempts have been made to obtain further information; however, it has not been made available.If additional information becomes available in the future, it will be properly updated.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, 3 devices were observed that are bent and 1 device was observed that the suture was slight frayed, was disengaged from the mouth of the anchor.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 can be attributed to the suture cracked/frayed.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device [5l29820] 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.
Event or Problem Description
This is report 2 of 3 for the same event.It was reported from (b)(6) that during bankart repair, it was observed that three anchor devices were bent right out of the box.According to the report, the boxes were sealed and in excellent condition.During in-house engineering evaluation of the photo provided by the facility, it was determined that the device was bent.There was a five minute delay in the surgery to get open a new implant.The procedure was completed successfully.There were no fragments generated.There were no adverse patient consequences reported.No additional information was 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.Correction: upon further investigation, the investigation summary has been updated as follows: 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.Multiple attempts have been made to obtain further information of device with lot number 5l29820; however, it has not been made available.If additional information becomes available in the future, it will be properly updated.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, 3 devices were observed that are bent and 1 device was observed that the suture was slight frayed, was disengaged from the mouth of the anchor.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 can be attributed to the suture cracked/frayed.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number:5l29820, 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.

• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10521253
• Report Number: 1221934-2020-02539
• Device Sequence Number: 16869549
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 06/30/2022
• Device Model Number: 222980
• Device Catalogue Number: 222980
• Device Lot Number: 5L29820
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1