MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN MENISCAL REPAIR SYSTEM PEEK 24 DEGREE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 228152

Device Problem Difficult to Advance (2920)

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

Event Date 07/18/2023

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)(6) incomplete.D4: the expiration date is currently unavailable.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.Investigation summary
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> a photo was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the first implant was partially deployed.A manufacturing record evaluation was performed for the finished device lot number: 9l78361, and no nonconformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the investigation findings, the reported complaint was confirmed.No more information was provided about the procedure that would help determine the root cause for the failure.We cannot discern a root cause for user to have experienced this issue.Based on the meniscal repair technique guide, it is necessary to choose the portal which most easily allows the delivery needle to be inserted perpendicular to the tear site to maximize your ability to reach and position your anterior meniscal repair site.In the case of deployment issue, it is possible that the trigger might have not fully been pressed until a click sound was heard which could cause the reported failure.The damage in the suture could be related when pulled out after it failed to deploy properly.As per ifu, it is important to use caution when tensioning the suture.Overtensioning may cause tissue damage and/or suture or implant breakage.Also, when penetrate the tissue to desired depth, again referencing the laser line at 10 mm on the needle as a secondary depth indicator as needed.Avoid damaging suture with needle.Finally, during the deployment it is necessary to 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¿.Fully release the trigger after deployment.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.

Event Description

It was reported by the healthcare professional in china that during a meniscal repair procedure on (b)(6) 2023, it was observed that the truespan meniscal repair system peek 24 degree device could not fix the meniscus after deployment.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.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.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.The device was received and evaluated.When performing the visual inspection, it could be observed that one plates was deployed.It does not show structural anomalies.The plates and the suture are in good conditions.The suture as foreign matter, presumably biological matter.The red trigger was found in a normal shape.No structural anomalies that can interfere with a full deployment were found.The functional test was performed to the second plate.The applier needle was introduced into a soft tissue simulator, the red trigger was fully squeezed, the second plate was successfully deployed, no obstruction or difficulties while deploying were found.It was verified that the pusher shaft tip is sliding out completely from the applier needle.A manufacturing record evaluation was performed for the finished device 9l78361 number, and no non-conformances related to the reported complaint condition were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the condition of the first plate, this complaint can be confirmed.A possible root cause for the issue experienced by the customer can be attributed to the procedural variables, such handling of the device or product interaction during procedure; it is possible that the depth penetration of the tissue was not maintained, therefore, the plates did not fully trespass the soft tissue and were pulled out along with the device, however, this cannot be conclusively determined.As per ifu: fully squeeze the red deployment trigger while maintaining depth positioning to deliver the first implant.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.

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.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.H4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.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.

• Brand Name: TRUESPAN MENISCAL REPAIR SYSTEM PEEK 24 DEGREE
• 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 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: 17451151
• MDR Text Key: 320309276
• Report Number: 1221934-2023-02924
• 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

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 Catalogue Number: 228152
• Device Lot Number: 9L78361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 09/01/2023; 09/05/2023
• Supplement Dates FDA Received: 09/05/2023; 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2022
• 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