MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 4.9MM HEALX ADV SP PEEK ANCHOR; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 222423

Device Problems Break (1069); Difficult to Advance (2920)

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

Event Date 06/14/2023

Event Type  malfunction  

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.H10 additional narrative: udi: (b)(4).E3: reporter is a j&j sales representative.H4: the device manufacture date is currently unavailable.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

This is report 1 of 2 for (b)(4).It was reported by the sales rep that during a rotator cuff repair procedure on (b)(6)2023, it was observed that the 4.9mm healx adv sp peek anchor device was difficult to advance then broke.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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, it could be observed that the threader assy, suture, inserter tip, dilator, and anchor were not received along with the device.Therefor this complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot 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.There were no details provided as to when this failure has occurred; therefore, a definite root cause for this failure cannot be determined.The possible root cause can be related to procedural variables, such handling of the device or when applied force applied while the anchor was misaligned in the axial direction which could damage the anchor.As per instructions for use: ensure that anchor is inserted axially to the bone hole (limit off-axis insertion).Ensure area of anchor insertion is free of soft tissue.Improper instrument use, axial misalignment or levering with the anchor upon insertion may result in anchor fracture or reduced performance at this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: 4.9MM 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 (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: 17220487
• MDR Text Key: 318091518
• Report Number: 1221934-2023-02548
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705030583
• UDI-Public: 10886705030583
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 222423
• Device Catalogue Number: 222423
• Device Lot Number: 150L544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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