MAUDE Adverse Event Report: DEPUY MITEK LLC US FASTIN RC 5MM OCORD W/O NDLS; SCREW, FIXATION, BONE

Catalog Number	222993
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the affiliate in brazil that on an unknown date, it was observed that the fastin rc 5mm ocord w/o ndls device had a shred problem during the procedure.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay 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: d4: the device expiration date is currently unavailable.H4: the device manufacture date is currently unavailable.The product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that there is an arthroscopic image provided, it was found that the suture was broken and frayed.The overall complaint was confirmed as the observed conditions of the fastin rc 5mm ocord w/o ndls would have contribute to the complained devices issues.Based on the investigation findings, the potential cause is traced to procedural variables such as; handling of the device or product interaction during procedure; the suture was over-tensioned causing the damage, 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 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.Udi (b)(4).

• Brand Name: FASTIN RC 5MM OCORD W/O NDLS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 19927057
• Report Number: 1221934-2024-02747
• Device Sequence Number: 12783329
• Product Code: HWC
• UDI-Device Identifier: 10886705008711
• UDI-Public: 10886705008711
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K060664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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: 222993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown