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

Model Number 222229

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 03/07/2022

Event Type  malfunction  

Event Description

It was reported by the customer in (b)(6) that during a rotator cuff repair surgery on (b)(6) 2022, it was observed that the 4.5 healix br anchor w/ocord device was broken upon opening its package.During in-house engineering evaluation of the photo provided by the customer, it was determined that the tip on the anchor device looked broken.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

(b)(4).Investigation summary both a photo and the device were returned for evaluation.Upon visual inspection of the photo, it could be observed that the device was not inside its original packaging.The photo showed the device lying on a table, and was inside a transparent plastic bag.The tip of the anchor looked broken.According with the visual inspection performed of the photo provided, this complaint cannot be confirmed.An anchor breakage without using was reported, however, the device shown in the photo was not inside its original packaging.The possible root cause for the broken anchor could be attributed to procedural variables, such handling of the device or product interaction during procedure; axial misalignment or bending force was applied to the tip of the device.As per ifu: inserting the awl less than the specified depth, axial misalignment or levering with the anchor upon insertion, may result in anchor fracture.Upon visual inspection of the sample received, it was revealed that the anchor and the suture card were not received along with the device; also, the suture was not in place.The shaft and the inserter tip were in good conditions.This complaint cannot be confirmed due to the anchor was not returned for evaluation.An anchor breakage without using was reported, however, the device is not inside its original packaging.The possible root cause for the broken anchor can be attributed to procedural variables, such handling of the device or product interaction during procedure.As per ifu: axial misalignment or levering with the anchor upon insertion, may result in anchor fracture.A manufacturing record evaluation was performed for the finished device (8l25441) number, and no non-conformances were identified.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, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: 4.5 HEALIX BR ANCHOR W/OCORD
• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 14218687
• MDR Text Key: 291502916
• Report Number: 1221934-2022-01231
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705007769
• UDI-Public: 10886705007769
• 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

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: 222229
• Device Catalogue Number: 222229
• Device Lot Number: 8L25441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• 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