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

Model Number 228152

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 09/19/2022

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.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.

Event Description

This is report 2 of 2 for (b)(4).It was reported by a healthcare professional in china that during a meniscal repair procedure on (b)(6) 2022, it was observed that the two plates on the truespan meniscal repair system peek 24 degree device were deployed at the same time and the needle was deformed after the first firing.They changed to another one but the same issue occurred.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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

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 and functional test of device received.The visual inspection of the second device revealed that both implants were deployed, and they were still in the suture.The suture was not in the needle.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.The device has no structural damages on its body.Manufacturing record evaluation was performed for the finished device lot number: 9l11309, and no nonconformances were identified.According with the visual inspection of the implants, this complaint can be confirmed.The possible root cause for the deployment failure reported could be related to a trigger mishandling, if the trigger was activated unintended, the deployment mechanism starts its process and when the trigger was used in the procedure, both implants would be deployed at the same time in the first shoot.As per ifu, it is necessary to use a calibrated probe, measure the width of the meniscal tissue to be repaired and set the adjustable depth.Also, during needle insertion use a malleable graft retractor or slotted cannula to prevent the needle from catching on or damaging soft tissue; once inside the joint space, remove the instrument.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.

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 apropriate.H10 additional narrative: investigation summary:photos were received and evaluated.Upon visual inspection of the photos, it appeared that the needle of one of the devices was deformed, also the other photo shows both implants deployed outside of the gun; therefore, this complaint can be confirmed for all the reported issues.A manufacturing record evaluation was performed for the finished device lot number: 9l11309, and no nonconformances were identified.The photos do not provide enough evidence to determine root cause.Without physical evaluation of the devices reported, we cannot establish a root cause for the issue experienced by the customer.The possible root cause for the bent needle can be attributed to procedural variables, such handling of the device or product interaction during procedure; the needle may have been forced upwards while it was inserted into the soft tissue.The possible root cause for the deployment failure could be related when not inserting the needle to the proper depth for deployment which have caused blocking insertion of the first implant, and when this occurred may have felt resistance and did not pull the trigger all the way.This would result in the first implant being only partially deployed.Then, when the trigger was pulled again both implants would be deployed at the same time, however, this cannot be conclusively determined.As per ifu, it is necessary to use a calibrated probe, measure the width of the meniscal tissue to be repaired and set the adjustable depth.At desired depth, fully squeeze the red deployment trigger while maintaining depth positioning to deliver the first 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, depuy synthes 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.

• Brand Name: TRUESPAN MENISCAL REPAIR SYSTEM PEEK 24 DEGREE
• 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 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: 15509362
• MDR Text Key: 300870000
• Report Number: 1221934-2022-02995
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026029
• UDI-Public: 10886705026029
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K153667
• 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,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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: 9L11309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• 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