MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINELOOPPLUS ANCHOR W/OC DS; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 210709

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  malfunction  

Event Description

It was reported by the customer in (b)(6) that before to a shoulder instability surgery on (b)(6) 2021, it was observed that the lupineloopplus anchor w/oc ds device was deformed upon opening its package.During in-house engineering evaluation of a photo provided by the customer, it was determined that the anchor was deformed, and still attached to the inserter via the tensioned suture.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

Udi: (b)(4).Investigation summary: according to the information received, it was reported that before the surgery of shoulder instability, opened the packing (did not use), it was found that the anchor was deformed (as the photo shows).No additional information could be provided.The packaging is intact without deformation or damage.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, it was observed that the anchor was deformed, and still attached to the inserter via the tensioned suture.The complaint is confirmed.A manufacturing record evaluation was performed for the finished device lot number: 8l25782, and no nonconformances were identified.The photos do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.The devices must be stored in cool dry place, or else deformation issues can occur.The probable root cause of this failure is that the devices were exposed to an elevated temperature before it was opened in the operating room prior to surgery.The elevated temperature and the slight tension on the suture could result in the bending of the anchor.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.As per ifu- 108805 store in a cool dry place.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.

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.The product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection of the photos, it was observed that the anchor was deformed, and still attached to the inserter via the tensioned suture.The complaint is confirmed.A manufacturing record evaluation was performed for the finished device lot number: 8l25782, and no non conformances were identified.A manufacturing investigation was previously performed; as a result, there is a 100% control at different stages of production of: anchor tightening, by a torque meter + anchor/shaft assembly + anchor/shaft gap with a measuring gauge.The operator has a very clear information: a green or red light informs if the torque meter complies or not; also, before putting in the tray, check that the loop is on the flat side of the is on the flat side of the anchor and that there is no there is no play between the anchor and the shaft.Finally, 100% visual control: check that no degradation on the suture and on the anchor is present.We cannot determine if the suture is under tension because the anchor is damage.There has been a closer look on the in-process controls.The results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the document reviewed.The sample was characterized by scanning electron microscope (sem); as a result, the images show evidence of plastic deformation.When polylactic acid (pla), the component of this device, is exposed to temperatures over 21 degrees c, its structure gets compromised as it tents to lose mass, it provides flexibility to the polymer chains producing a decrease in the degree of crystallinity of the structure and the microhardness values causing these types of deformations.These damages have typical characteristics of material exposed to temperatures higher than recommended, however this cannot be conclusively determined."(b)(4)".Based on the results, the probable root cause of this failure is that the devices were exposed to an elevated temperature before it was opened in the operating room prior to surgery.The elevated temperature and the slight tension on the suture could result in the bending of the anchor.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.As per ifu- 108805 store in a cool dry place.As part of mitek¿s 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.Device history lot: there was no non conformance regarding this lot.

• Brand Name: LUPINELOOPPLUS ANCHOR W/OC DS
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 13011765
• MDR Text Key: 285455118
• Report Number: 1221934-2021-03756
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001071
• UDI-Public: 10886705001071
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: 210709
• Device Catalogue Number: 210709
• Device Lot Number: 8L25782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1