MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 0 DEGREE PEEK; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228150

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (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.Udi: (b)(4).

Event Description

It was reported by the affiliate via email that a surgery began on september 24 with the doctor to repair the broken meniscus.The doctor asked for the 12 ° meniscal suture, go to the table, indicate the steps to place it as indicated in the training, also it was not the first time that the doctor placed this first suture, it did not fail, it got very well.At the time of placing the second, the doctor shoots the first point and this failure leaves the implant outside.He asks for a 3 0° meniscal suture and the exact same thing happens.Leaving the implants on the outside.Additional information provided by the affiliate with the suture that presented optimal functioning, a part of the meniscus was corrected, the rest was remodeled by dr.(b)(6) with a basketh.It was also reported he only fragment that was generated was the implant that expelled the meniscal suture, which was not left in the patient and there were no consequences for the patient.The reported devices will be returned for evaluation.

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.Investigation summary
=
> according to the information provided, it was reported that surgery begins on september 24 with dr.Go.Find the broken meniscus, ask for 12 ° meniscal suture, go to the table, indicate the steps to place it as indicated in the training, also it was not the first time that the doctor placed this first suture, it did not fail, it got very well.At the time of placing the second, the doctor shoots the first point and this failure leaves the implant outside.He asks for a 3 0 ° meniscal suture and the exact same thing happens.Leaving the implants on the outside.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, both implants are deployed but held in place by suture.The silicon sleeve was in good conditions.The complaint reported was confirmed.The photo do not provide enough evidence to determine root cause.The possible root cause for the reported failure can be attributed to low tension applied in the trigger or the internal spring can be defective.This cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number:6l41078, and no non-conformances 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 the device has been evaluated, 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 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 edwatch will be filed as appropriate.H10 additional narrative: investigation summary : according to the information provided, it was reported that surgery begins on (b)(6) with dr.(b)(6).Find the broken meniscus, ask for 12 ° meniscal suture, go to the table, indicate the steps to place it as indicated in the training, also it was not the first time that the doctor placed this first suture, it did not fail, it got very well.At the time of placing the second, the doctor shoots the first point and this failure leaves the implant outside.He asks for a 3 0 ° meniscal suture and the exact same thing happens.Leaving the implants on the outside.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, both implants are deployed but held in place by suture.The silicon sleeve was in good conditions.The complaint reported was confirmed.The photo do not provide enough evidence to determine root cause.The possible root cause for the reported failure can be attributed to low tension applied in the trigger or the internal spring can be defective.This cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number:6l41078, and no non-conformances 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.,according to the information received, it was reported that surgery begins on (b)(6) with dr.(b)(6).Find the broken meniscus, ask for 12 ° meniscal suture, go to the table, indicate the steps to place it as indicated in the training, also it was not the first time that the doctor placed this first suture, it did not fail, it got very well.At the time of placing the second, the doctor shoots the first point, and this failure leaves the implant outside.He asks for a 3 0 ° meniscal suture and the exact same thing happens.Leaving the implants on the outside the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Visual analysis of the returned device, determined that both implants and the suture are deployed from the needle.Testing of trigger¿s functionality revealed that was working as expected.A manufacturing record evaluation was performed for the finished device lot number: 6l41078, and no non-conformances were identified.Based on the information currently available and due to the condition of the implants received, this complaint can be confirmed.The possible root cause for the reported failure can be attributed to the user didn't pull fully the red trigger.As per ifu-113244, indicate the instructions for user to handle the device at the insertion phase.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¿.Fully release the trigger after deployment.In this case, it can be concluded that root cause of the failure reported is due to handling of the device, however; it cannot be conclusively affirmed.As part of mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications 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.

• Brand Name: TRUESPAN 0 DEGREE PEEK
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10670506
• MDR Text Key: 211307056
• Report Number: 1221934-2020-02970
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026005
• UDI-Public: 10886705026005
• Combination Product (y/n): N
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/24/2020

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 Expiration Date: 10/31/2022
• Device Model Number: 228150
• Device Catalogue Number: 228150
• Device Lot Number: 6L41078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 11/13/2020; 04/12/2021; 04/18/2021
• Supplement Dates FDA Received: 11/16/2020; 04/13/2021; 04/19/2021
• Patient Sequence Number: 1