MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 5.5MM HEALX ADV SP PEEK ANCHOR; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222425

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown implant.Part and lot number are unknown.Without the specific part number; the udi number, 510-k number and manufacturing site name are unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 Description

It was reported by the healthcare professional through a marketing survey that the healix advance sp biocomposite anchor cut the suture in two cases and the inserter bent on hard bone in two cases.Another like device was used to complete the procedure.No patient consequences or surgical delay reported.The device is not available to be returned for evaluation.

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.H11 additional narrative: d1, d2, d3, d4, g1-2, g5: the product code was reported as unknown on the initial report; and has been updated accordingly.Therefore, catalog, lot number, manufacturing information and udi have been updated respectively.Udi: (b)(4) incomplete.The lot number was unknown.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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: 5.5MM HEALX ADV SP PEEK ANCHOR
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle MA CH-24 00; SZ CH-2400
• MDR Report Key: 11472801
• MDR Text Key: 245980808
• Report Number: 1221934-2021-00829
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K182941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 222425
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1