MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL TRUESPAN 24 DEGREE PLGA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number 228162

Device Problem Device-Device Incompatibility (2919)

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

Event Date 02/13/2024

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.D4: the expiration date is currently unavailable.H4: the device manufacture date is unknown.(b)(4) as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported by the health authority from switzerland that during a knee arthroscopy surgical procedure with knee repair performed on (b)(6) 2024 it was observed that the truespan 24 degree plga device would not fire the back stops.It was reported that the instrument was blocked.It was not reported if a spare device was available for use.It is unknown how the procedure was completed.There was no surgical delay or patient consequences.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 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.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.

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: d4, h4: the expiration date and device manufacture date were reported as unknown on the initial report; and have been updated accordingly.Therefore, udi: (b)(4).Investigation summary the product was returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned device.Visual inspection found that truespan 24 degree plga had the first plate deployed, the plates and the suture were still on the shaft, also the red trigger was broken and completely loose.No other anomalies could be observed.A functional test was unable to be performed due to the condition of the device.The overall complaint was confirmed as the observed condition of the truespan 24 degree plgawould contribute to the complained device issue.Based on the investigation findings, the potential cause could be traced to the procedural variables, such handling of the device or product interaction during procedure, 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 instructions for use (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 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.

• Brand Name: TRUESPAN 24 DEGREE PLGA
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; 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: 18788782
• MDR Text Key: 336400652
• Report Number: 1221934-2024-00576
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026050
• UDI-Public: 10886705026050
• 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: Other,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 228162
• Device Lot Number: 203L317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/25/2024; 04/17/2024; 04/17/2024
• Supplement Dates FDA Received: 03/26/2024; 04/17/2024; 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1