MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 4.9MM HEALX ADV SP PEEK ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 222423

Device Problems Degraded (1153); Mechanical Problem (1384); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Date 05/25/2022

Event Type  malfunction  

Event Description

It was reported by the sales rep that during an unknown procedure on (b)(6) 2022, it was observed that anchor could not be released from the inserter.During an in-house engineering evaluation, it was determined that the device was stripped/damaged/worn.Another device was used to complete the procedure.No patient consequences or 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This event was reported by the sales rep investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Upon visual inspection revealed marks of wear in the device.It could be detected that the peek anchor, peek dilator and the suture were not attached in the device.The threader assembly was missing.It could be observed, the anchor was found damaged with deformed condition.Finally, it could be found biological residues in handle of the device, the tip of the device was found in good conditions and no anomalies were found.A manufacturing record evaluation was performed for the finished device lot number: 9l17991, and no non-conformances were identified.According with the visual inspection result, this complaint can be confirmed.A possible root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure.When trying to insert the anchor, the anchor can lead to deformed and could be get stuck in the inserter if a pilot hole is not created adequate to allow proper anchor placement.However, this cannot be conclusively affirmed.As per the instructions for use, anchors are designed to lock into cortical or cancellous bone.Bone stock must be adequate to allow proper and secure anchor placement.Incomplete insertion or over-tensioning or poor bone quality may result in anchor pullout.When hard bone is encountered, it is recommended to use an awl, drill, or similar instrument to create a pilot hole in bone prior to anchor insertion.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.Device history lot: a manufacturing record evaluation was performed for the finished device lot number: 9l17991, and no non conformances were identified.Udi: (b)(4).

• Brand Name: 4.9MM HEALX ADV SP PEEK ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT MITEK; 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: 15043484
• MDR Text Key: 302376930
• Report Number: 1221934-2022-02165
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• 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: 9L17991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1