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

Model Number 222205

Device Problems Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

It was reported by the customer in (b)(6) that during a reconstruction of medial patellar ligament procedure on (b)(6) 2022, it was observed that the shaft could not be removed on the 4.5 healix peek anch.W/ocord device.During in-house engineering evaluation, it was determined that there was biological matter over the inserter on the device.Another like device was used to complete the surgery.There were no adverse consequences to the patient nor surgical delay reported.No additional information could be provided.

Manufacturer Narrative

Additional narrative: udi: (b)(4).Investigation summary: the complaint device was received and evaluated.Upon visual inspection, it was observed that, the anchor's tip was cut, the anchor is assembled on the device's inserter and is hard to pull it out.The suture was not returned.The anchor was removed from the inserter by applying force counter-clockwise.At magnification of the inserter tip, it was observed rests of biological matter over the inserter, once removed, the anchor was inserted and removed off the inserter with no restriction.A manufacturing record evaluation was performed for the finished device 8l36855 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.According with the visual inspection result, this complaint can be confirmed.A root cause for the reported condition can be attributed to procedural variables, such handling of the device or product interaction during procedure; excessive force may was applied to the anchor when tightening, therefore, the anchor got stuck on the inserter tip, however, this cannot be conclusively determined.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.

• Brand Name: 4.5 HEALIX PEEK ANCH.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 ; 8472871282
• MDR Report Key: 14075157
• MDR Text Key: 292508817
• Report Number: 1221934-2022-01123
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705007530
• UDI-Public: 10886705007530
• 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,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

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 222205
• Device Catalogue Number: 222205
• Device Lot Number: 8L36855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2021
• 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