MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 222296

Device Problems Crack (1135); Device Damaged Prior to Use (2284)

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

Event Date 04/15/2022

Event Type  malfunction  

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, the observation revealed the anchor was cracked.It was not possible to see the condition of the packaging.A manufacturing record evaluation was performed for the finished device lot number: 8l25563, and no non-conformances related to the reported complaint condition were identified.Based on the condition of the anchor, this complaint can be confirmed.The photo do not provide enough evidence to determine a specific root cause.A manufacture investigation was performed to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Based on the above, it is confirmed that the manufacturing process has been performed according to the validated processes.The root cause is not manufacturing related.The manufacturer demonstrated the controls in place to avoid this type of damage in the anchor.An in-process control has been performed on 9 parts chosen randomly by a certified operator and have been inspected also per (b)(4).Likewise, an inspection of the product and the process was made, the results show that this batch of product was processed without any incident; the results of production controls (100%) and in-process controls (9 samples) are all compliant.A training verification has been performed at the moment in the production where the issue could have occurred.Every employee has completed the training for the processes.The potential occurrence of having an anchor cracked has been evaluated 3 to over 115091 since 2016, per wi-6474 rev23 corresponding to defect over parts.Effect of having the anchor cracked has been evaluated in the wi-6474 rev23 by combining primality and severity levels.With a ratio of 0.0026 % < 0.02% and is ranking 1 (= improbable and negligeable).This risk is acceptable further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of (b)(4) devices that were released to distribution.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 Description

It was reported by the customer in china that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the 4.5 healix advance br 3 suture anchor w/ orthocord device was cracked upon opening its package.The anchor was not used.During in-house engineering evaluation, it was determined that the anchor was cracked.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: 4.5 HEALIX ADVANCE BR 3 SUTURE ANCHOR W/ ORTHOCORD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14853397
• MDR Text Key: 302962572
• Report Number: 1221934-2022-01906
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705021321
• UDI-Public: 10886705021321
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120078
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 222296
• Device Catalogue Number: 222296
• Device Lot Number: 8L25563
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/29/2022
• 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