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

Model Number 228152

Device Problem Device-Device Incompatibility (2919)

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

Event Date 11/11/2022

Event Type  malfunction  

Event Description

It was reported by a healthcare professional in china that during an anterior cruciate ligament reconstruction procedure on (b)(6) 2022, it was observed that two plates on the truespan meniscal repair system peek 24 degree device were deployed at the same time after the first firing.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, a follow-up will be filed as appropriate.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 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.Investigation summary: the complaint device has not been returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, it was only possible to see one implant deployed; the complaint reported was not confirmed.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more evidence to confirm the issue reported.The root cause for the issue experienced by the customer cannot be determined.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.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.A manufacturing record evaluation was performed for the finished device lot number: 8l77717, and no nonconformances were identified.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.

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.H10 additional narrative: 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: both the complaint device and a photo were provided by the customer and evaluated.The product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Visual inspection revealed that the first plate was partially deployed.There were no anomalies or structural damage on the outside of the device.The functional test was performed, the applier needle was introduced into a soft tissue simulator, the red trigger was fully squeezed, the two plates were successfully deployed, no obstruction or difficulties while deploying.It was verified that the pusher shaft tip is sliding out completely the applier needle.According with the functional test results, this complaint can be confirmed.The possible root cause for this issue can be attributed to the handling of the device, the operator did not squeezed the red trigger to its fully position.As per ifu, 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¿.Upon visual inspection of the photo, it was only possible to see one implant deployed; the complaint reported was not confirmed.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more evidence to confirm the issue reported.The root cause for the issue experienced by the customer cannot be determined.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.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.A manufacturing record evaluation was performed for the finished device lot number: 8l77717, and no nonconformances were identified.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: 16080506
• MDR Text Key: 308278148
• Report Number: 1221934-2022-04347
• Device Sequence Number: 1
• Product Code: MBI
• 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: 12/30/2022
• 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: 8L77717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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
• Patient Age: 42 YR
• Patient Sex: Male