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

Model Number 222425

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

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

Event Date 02/08/2022

Event Type  malfunction  

Event Description

It was reported by the customer that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the kite was bent at the base upon opening its package; and broke when attempted to use.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer 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 (8l25189), 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.

• 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 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: 13623325
• MDR Text Key: 289527400
• Report Number: 1221934-2022-00639
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705030606
• UDI-Public: 10886705030606
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 222425
• Device Catalogue Number: 222425
• Device Lot Number: 8L25189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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
• Patient Age: 50 YR
• Patient Sex: Female