MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL INTRAFX ADVBR SCW8X30 W/SMSHTH; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number 254807

Device Problem Break (1069)

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

Event Date 03/22/2024

Event Type  malfunction  

Event Description

It was reported by the sales rep in hungary that during an unspecified surgical procedure on (b)(6) 2024 the 2x 4580 fms duo+ pump/shaver device did not work, had no pressure.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.This is report 1 of 2 of the same event.

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.H4: the device manufacture date was unknown.D10: concomitant device: intrafx advbr scw8x30 w/smshth, therapy date: (b)(6) 2024.Udi: (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 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.H6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, 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 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.Visual inspection found that the device (kit of anchor and sheath) comes in used condition.Upon reviewing the sheath it was found that is broken at the proximal part.The overall complaint was confirmed as the observed condition of the intrafx advbr scw8x30 w/smshth would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to axial misalignment during the sheath placement with the sheath inserter tool and/or an incorrect inserter tool size.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 quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will b-e 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 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.D4, h4: the expiration date and device manufacture date have been added.

• Brand Name: INTRAFX ADVBR SCW8X30 W/SMSHTH
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, 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 02767 ; 3035526892
• MDR Report Key: 19037644
• MDR Text Key: 339301725
• Report Number: 1221934-2024-01078
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705026739
• UDI-Public: 10886705026739
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K160804
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/03/2024

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: 254807
• Device Lot Number: 166L141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/11/2024; 04/23/2024; 04/30/2024
• Supplement Dates FDA Received: 04/12/2024; 04/26/2024; 05/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2023
• 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