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

Catalog Number 228152

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/27/2024

Event Type  malfunction  

Event Description

This is report 2 of 2 for (b)(4) it was reported by the healthcare professional in new zealand that during a meniscal repair surgical procedure on an unknown date, it was observed that the trigger on the truespan 24 degree peek device did not release the impant.A second device was opened and the same thing happened, did not deploy the implant.There was no delay in the procedure reported.There were no adverse patient consequences reported.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 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.Device was used for treatment, not diagnosis.H10 additional narrative: (b)(4) device evaluation: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device lot number (233l174), and no non-conformance was 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.B5: additional information confirmed that the surgery was completed by opening up a new device with a different batch number.H10 correction narrative: correction b3: the event date was reported as 1/1/2024 in the initial report.The event date has been updated accordingly.

• Brand Name: TRUESPAN 24 DEGREE PEEK
• 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 ; 3035526892
• MDR Report Key: 19039740
• MDR Text Key: 339321392
• Report Number: 1221934-2024-01090
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 10886705026029
• UDI-Public: 10886705026029
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 04/04/2024

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: 228152
• Device Lot Number: 233L174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• 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