MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL TRUESPAN 12 DEGREE PLGA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 228161

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/19/2024

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 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.Device was used for treatment, not diagnosis.H10 additional narrative: e3: reporter is a j&j sales representative.D10: concomitant med products and therapy dates: truespan 12 degree plga device, on (b)(6) 2024.D4, h4: the lot number was unknown; therefore, the expiration date and device manufacture date were unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.(b)(4).

Event Description

This is report 1 of 2 for (b)(4) it was reported by the sales rep from switzerland that during an unspecified surgical procedure, it was discovered that while deploying the anchor from the truespan 12 degree plga device, it did not go through the meniscus even though the surgeon pressed the needle through it and made sure that the sleeve was touching the meniscus.It was reported that the event happened twice with two devices.There were no delays in the surgical procedure.It was reported that a spare device was available for use.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

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.Device was used for treatment, not diagnosis.H4, udi: the device manufacture date and expiration date were unavailable in the initial medwatch report.Therefore, the udi was incomplete.The device manufacture date and expiration date has been identified and updated accordingly.Udi: (b)(4).Investigation summary : the product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection and functional testing of the returned device.Visual inspection found that truespan 12 degree plga had the 1st plate deployed and still attached to the suture.The plate and the suture are in good conditions.The red trigger was found in a normal shape.No other anomalies could be observed.A 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.The overall complaint was confirmed as the observed condition of the truespan 12 degree plga would contribute to the complained device issue.Based on the investigation findings, the potential cause could be traced to when not inserting the needle to the proper depth for deployment which could have caused blocking insertion, when this occurred resistance may have been felt and the trigger did not pull all the way.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, it is important 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, and it has been determined that no corrective and/or preventative action is proposed.There was no nonconformance regarding this lot.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes mitek quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

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.Device was used for treatment, not diagnosis.H10 additional narrative: d4, udi: lot number the device lot number was unknown the initial medwatch report.The lot number has been identified as 197l757 and the udi has been updated accordingly.Udi: (b)(6).

• Brand Name: TRUESPAN 12 DEGREE PLGA
• 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: 18969288
• MDR Text Key: 339322189
• Report Number: 1221934-2024-00971
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026043
• UDI-Public: 10886705026043
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K153667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2024

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: 228161
• Device Lot Number: 197L757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 04/08/2024; 04/11/2024
• Supplement Dates FDA Received: 04/08/2024; 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2023
• 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