MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN 24 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228152

Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983)

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

Event Date 04/08/2022

Event Type  malfunction  

Event Description

It was reported by the affiliate in (b)(4) that during a meniscal repair surgery on (b)(6)2022, it was observed that the first implant on the truespan 24 degree peek device got stuck when fired.According to the report, the implant was repositioned and fired again but two implants came out together.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

Additional narrative: udi: (b)(4).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.

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: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.Investigation summary : the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.A manufacturing record evaluation was performed for the finished device lot number (8l67875), and no non-conformance was identified.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

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.Visual inspection reveals that there are no anomalies or structural damage on the outside of the device.It was identified that both implants and suture were no longer attached to the needle shaft and the sleeve was found damage.Finally, the red trigger was reviewed and tested, it performed as intended.The pusher rod that places the implants is also in good shape, no structural anomalies could be found.A manufacturing record evaluation was performed for the finished device lot number: 8l67875, and no nonconformances were identified.Since the condition of the device received and the result of the visual inspection, this complaint cannot be confirmed due to no defect found on the device.A possible root cause for the deploy failure could be related when not inserting the needle to the proper depth for deployment which have caused blocking insertion after deploying the first implant, and when attempt to fire the implant against the tissue, it can feel a resistance and excessive force could have caused stress on the handle thus causing the handle mechanism to break.As per ifu, for the needle insertion, it is necessary use a calibrated probe, measure the width of the meniscal tissue to help insert into the joint.Set the adjustable depth stop to minimize tissue penetration depth.Also, at desired depth, squeeze the red deployment trigger while maintaining depth positioning to deliver the second implant.The implant is fully deployed when you hear an audible ¿click¿.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.D9: the date device returned to manufacturer was inadvertently missed on the previous report; and has been updated to reflect the correct information.

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.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

• Brand Name: TRUESPAN 24 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 3035526892
• MDR Report Key: 14211771
• MDR Text Key: 290103588
• Report Number: 1221934-2022-01226
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026029
• UDI-Public: 10886705026029
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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: 228152
• Device Catalogue Number: 228152
• Device Lot Number: 8L67875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2022
• Initial Date FDA Received: 04/26/2022
• Supplement Dates Manufacturer Received: 05/26/2022; 08/23/2022; 09/01/2022
• Supplement Dates FDA Received: 05/31/2022; 08/24/2022; 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• 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