MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL INTRAFX ADV POLYPROSHTHSM 30MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 254825

Device Problem Material Deformation (2976)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: udi: (b)(4).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.A manufacturing record evaluation was performed for the finished device lot number (7l51320), and no non-conformances were identified.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 to which this complaint is observed in the field.

Event Description

It was reported by the customer in (b)(6) that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2022, it was observed that one side of the sheath quadrant on the intrafx adv polyproshthsm 30mm device was bent; and was not seating on the sheath inserter correctly prior to inserting.Another like device was used to complete the procedure with a minute of delay.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: INTRAFX ADV POLYPROSHTHSM 30MM
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13663472
• MDR Text Key: 288199717
• Report Number: 1221934-2022-00719
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705027521
• UDI-Public: 10886705027521
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160804
• 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: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 254825
• Device Catalogue Number: 254825
• Device Lot Number: 7L51320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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