MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 24 DEGREE PLGA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228162

Device Problems Migration or Expulsion of Device (1395); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 via complaint submission tool that during a meniscal repair, while using truespan meniscal repair system plga 24 degree to attempt a vertical repair on a meniscus tear, on the 1st truespan that was used at 18mm needle exposure, the implant failed to secure on the knee capsule.Subsequently, on the 4th truespan with 18mm needle exposure used also happened similar issue.A total of nine truespans were used, issue happened on two guns.They were no issues on the other seven guns.There was no delay in the surgery and no patient consequences.

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: investigation summary: event description: it was reported by affiliate via complaint submission tool that during a meniscal repair, while using truespan meniscal repair system plga 24 degree to attempt a vertical repair on a meniscus tear, on the 1st truespan that was used at 18mm needle exposure, the implant failed to secure on the knee capsule.The device was received and evaluated, on the visual inspection, one of the implants was received in deployed condition which shows that the user deployed the first implant.When performing the functional test, the second implant was able to be deployed without any issues.No structural anomalies were observed on both implants.According with the visual inspection result, this complaint cannot be confirmed and therefore unable to be replicated for the reported failure to secure/seat/insert implant on the knee.We cannot determine a root cause why the customer experienced the reported failure.A manufacturing record evaluation was performed for the finished device lot number (6l86162), and no non-conformances related to the reported complaint condition were identified.At this point, 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: d10, 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 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.Correction: h6: device codes: upon complaint review, it was determined that the device code that was reported on the initial report was not an accurate representation of the complaint; and therefore, has been updated accordingly to reflect the correct information.

• Brand Name: TRUESPAN 24 DEGREE PLGA
• 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: 10653627
• MDR Text Key: 210625002
• Report Number: 1221934-2020-02940
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026050
• UDI-Public: 10886705026050
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/23/2020

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: 03/31/2023
• Device Model Number: 228162
• Device Catalogue Number: 228162
• Device Lot Number: 6L86162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 10/23/2020; 11/06/2020; 11/06/2020
• Supplement Dates FDA Received: 10/26/2020; 11/06/2020; 11/06/2020
• Patient Sequence Number: 1