MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE LOOP DS W/ORTHOCORD *EA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	222981
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer 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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during a shoulder joint instability procedure on (b)(6) 2021, it was observed that the lupine loop ds w/orthocord device was broken.Another like device was used to complete the procedure with a 15 minute delay.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.Investigation summary: according to the information received, it was reported that during shoulder joint instability procedure, it was discovered the deformation of three lupine loop dual suture anchor - orthocord in a row - curvature and altered anchor radii, tensioned threads.Two anchors are broken, we can bring the third one.Doctor has been installing our product since 2013, this situation happened for the first time.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, 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 within the handle at the proximal end of the inserter.A manufacturing record evaluation was performed for the finished device lot number: 5l13545, and no nonconformances were identified.Hands on analysis should provide the evidence necessary to confirm the root cause, but it was discarded.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- 108180.There was no information provided regarding this condition.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.

• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11231092
• Report Number: 1221934-2021-00245
• Device Sequence Number: 3494443
• Product Code: MAI
• UDI-Device Identifier: 10886705008599
• UDI-Public: 10886705008599
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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: 06/30/2022
• Device Model Number: 222981
• Device Catalogue Number: 222981
• Device Lot Number: 5L13545
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1