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

Catalog Number 228152

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported by the healthcare professional in china that during a meniscal repair surgical procedure on (b)(6) 2024 the truespan 24 degree peek device firing trigger was broken and the tip of the needle was deformed.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be 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.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.D4: the device expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.(b)(4).

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: the investigation has been updated to reflect the correct information: investigation summary according to the information received, it was reported that during the surgery, noted the firing trigger was broken and the tip of the needle was deformed(as the photo shows).Another device was used to complete the surgery.There were no adverse consequences to the patient.The product was not returned to depuy synthes, however photos were provided for review.See attachment ( (b)(4) ).The photo investigation revealed that truespan 24 degree peek is shown in used condition.The needle is bent and the red trigger is completely retracted by itself which is a sign of trigger breakage.The overall complaint was confirmed as the observed condition of the truespan 24 degree peek would contribute to the complained device issue.Based on the investigation findings, the potential root cause can be attributed to procedural variables, such handling of the device or product interaction during procedure; an excessive manipulation of the device, tilting movements of the applier needle while it was inserted causing the needle to be bent and therefore a mechanical obstruction of the plate when it was going to be deployed; this obstruction and the force applied to the trigger are contributive factors of the broken trigger, however, this cannot be conclusively determined.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 complaint condition.As part of depuy synthes 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.Device history review: there was no non conformance regarding this lot.

• Brand Name: TRUESPAN 24 DEGREE PEEK
• 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 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 18911553
• MDR Text Key: 337741885
• Report Number: 1221934-2024-00884
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: 197L801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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