MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL INTRAFX ADVBR SCW 8X23W/SMSHTH; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	254801
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that during an unspecified surgical procedure on (b)(6) 2024 the intrafx advbr scw 8x23w/smshth device was broken.The interface nail was broken off during implantation and all the broken parts were removed.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.
Additional 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.H11 additional narrative: the product has not returned to depuy synthes mitek, however a photo was provided for review.The photo investigation revealed that intrafx advbr scw 8x23w/smshth anchor was broken.The anchor had foreign matter, presumably biological matter.The overall complaint was confirmed as the observed condition of intrafx advbr scw 8x23w/smshth would contribute to the complained device issue.Based on the investigation findings, the potential cause for the broken anchor can be traced to off axis insertion and levering during insertion.As per ifu use instructions are provided, 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 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.H4: the device manufacture date was unknown.Udi: (b)(4).

• Brand Name: INTRAFX ADVBR SCW 8X23W/SMSHTH
• Common Device Name: 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: 19730430
• Report Number: 1221934-2024-02421
• Device Sequence Number: 8290098
• Product Code: MAI
• UDI-Device Identifier: 10886705026661
• UDI-Public: 10886705026661
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K160804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 254801
• Device Lot Number: 179L147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown