MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.9 HEALIX ADV SP PEEK CE; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 228055

Device Problems Product Quality Problem (1506); Material Deformation (2976)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

It was reported by the healthcare professional in china that during an achilles repair procedure on (b)(6) 2023, it was observed that the 4.9 healix adv sp peek ce device pulled out.During in-house engineering evaluation, it was determined that the device was deformed/bent.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

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.Device was used for treatment, not diagnosis.D4: the expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.G4:510(k): the 510(k) information is currently unknown.Investigation summary: the complaint device was returned for evaluation.Upon visual inspection, the device comes with its original packaging.There are no structural anomalies on the shaft, the anchor and peek dilator.The threader tab wire (blue kite) was found damaged due to a force applied against itself.A manufacturing record evaluation was performed for the finished device 9l62932 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 cannot be confirmed for the missing kite since the kite was found within the device.The potential root cause for the bent wire can be attributed to possibly while opening the foil pouch and sliding the device out of its white paper holder, the blue kite slipped out of its retaining hole causing the wire to be bent, 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 monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.Udi: (b)(4).

• Brand Name: 4.9 HEALIX ADV SP PEEK CE
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• 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: 18372919
• MDR Text Key: 331191161
• Report Number: 1221934-2023-04697
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228055
• Device Lot Number: 9L62932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male