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	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an orthopedic procedure, it was discovered that the anchor on the fastin rc 5.0 w/ocord w/ndls device pulled out.It was not reported if there were any delays to the surgical procedure.It was reported that a spare device was used to complete the surgery.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
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.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.H11: additional narrative: e1: the reporter¿s complete facility name was not provided.Investigation summary the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the device is shown in used condition.Over its foil pouch.The anchor is not attached to the inserter shaft.The anchor is not visible in the photo.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 potential cause is traced to procedural variables, such handling of the device or product interaction during procedure; it is not unreasonable that during the procedure, poor bone quality may be encountered, therefore the anchor was pulled out.As per ifu; incomplete insertion or poor bone quality may result in anchor pullout.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 record review: a device history review was performed and no non-conformances were identified related to the reported condition.
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.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.D9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted 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.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.H11: additional narrative: correction: updated device evaluation: upon further investigation, the evaluation of the device has been revised with the following findings: h6.Investigation findings, investigation conclusions and component codes have been updated accordingly.Investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the device comes in used condition.Biological matter can be observed on the device.The anchor is not attached to the inserter shaft and it was not returned.Without the anchor we cannot verify the issue reported.The overall complaint was not confirmed as the observed condition of the fastin rc 5.0 w/ocord w/ndls would have not contributed to the complained device issue.Based on the findings, the investigation could not draw any conclusions and no potential cause about the reported event can be established due to the insufficient evidence provided.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.Photo evaluation: visual inspection of the returned photo found that the device is shown in used condition.Over its foil pouch.The anchor is not attached to the inserter shaft.The anchor is not visible in the photo.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 potential cause is traced to procedural variables, such handling of the device or product interaction during procedure; it is not unreasonable that during the procedure, poor bone quality may was encountered, therefore the anchor was pulled out.As per; incomplete insertion or poor bone quality may result in anchor pullout.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.

• 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: 21643284
• Report Number: 1221934-2025-01002
• Device Sequence Number: 12701596
• Product Code: HWC
• UDI-Device Identifier: 10886705008698
• UDI-Public: (01)10886705008698(10)214L001(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): 03/19/2025

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: 214L001
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 04/04/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/02/2025; 04/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown