MAUDE Adverse Event Report: DEPUY MITEK LLC US FASTIN RC 5.0 W/OCORD W/NDLS; SCREW, FIXATION, BONE

Catalog Number	222991
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
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 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.Device was used for treatment, not diagnosis.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 was not returned to j&j medtech orthopaedics, however a photo was provided for evaluation.Visual inspection of the returned photo found that the anchor is deformed.Sutures are impregnated with biological matter.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the fastin rc 5.0 w/ocord w/ndls would have contributed to the complained device issue.Based on the investigation findings, the root cause is traced to procedural variables, such handling of the device or product interaction during procedure; it is not unreasonable that hard bone surface may was encountered during insertion besides axial misalignment may occurred, therefore the screw was deformed.As per the instructions for use.The anchor is screwed directly into the bone without pre-drilling.Twist the fastin rc inserter clockwise until anchor is below the surface of the bone; two depth marks are provided on the shaft as a reference.The two longitudinal dashed lines at the distal end of the inserter indicate the position of the suture limbs as they are positioned through the distal suture eyelet of the anchor.The two longitudinal solid lines at the distal end of the inserter indicate the position of the suture limbs as they are positioned through the proximal suture eyelet of the anchor.The fastin rc can be passed directly through soft tissue when tissue quality is appropriate, or directly into the prepared bone.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 j&j medtech orthopaedics 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.
Event or Problem Description
It was reported that during a total hip replacement the fastin rc 5.0 w/ocord w/ndls device anchor was bent, removed the anchor from patient.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be 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 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
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 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the tip of the anchor deformed and the sutures impregnated with biological matter.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the fastin rc 5.0 w/ocord w/ndls would have contributed to the complained device issue.Based on the investigation findings, the root cause is traced to procedural variables, such handling of the device or product interaction during procedure.It is not unreasonable that hard bone surface may was encountered during insertion besides axial misalignment may occurred, therefore the screw was deformed.As per the instructions for use.The anchor is screwed directly into the bone without pre-drilling.Twist the fastin rc inserter clockwise until anchor is below the surface of the bone; two depth marks are provided on the shaft as a reference.The two longitudinal dashed lines at the distal end of the inserter indicate the position of the suture limbs as they are positioned through the distal suture eyelet of the anchor.The two longitudinal solid lines at the distal end of the inserter indicate the position of the suture limbs as they are positioned through the proximal suture eyelet of the anchor.The fastin rc can be passed directly through soft tissue when tissue quality is appropriate, or directly into the prepared bone.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 j&j medtech orthopaedics 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 lot: there was no non-conformances regarding this lot.

• Brand Name: FASTIN RC 5.0 W/OCORD W/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 02767 ; 3035526892
• MDR Report Key: 21967170
• Report Number: 1221934-2025-01639
• Device Sequence Number: 18173488
• Product Code: HWC
• UDI-Device Identifier: 10886705008698
• UDI-Public: (01)10886705008698(10)214L000(17)260731
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060664
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2025

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 Expiration Date: 07/31/2026
• Device Catalogue Number: 222991
• Device Lot Number: 214L000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/12/2025; 06/17/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/13/2025; 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown