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	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
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.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.H4: the device manufacture date is currently unavailable.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that during a lateral resection and removal of material procedure, it was discovered that the anchor thread on the fastin rc 5mm ocord w/o ndls device failed to detach from the insertion rod, despite multiple attempts during the procedure.The issue continued even outside the surgical setting, with several manual attempts unable to separate the thread from the rod.Visually, the component presented a possible fusion between the anchor and the insertion body, compromising the safe and effective use of the device.The surgical technique was adapted, and sample segregation was implemented to minimize any impact on the expected outcome of the procedure.It was not reported if there were any delays to the surgical procedure.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: h4: the device manufacture date has been updated accordingly.Investigation summary : the complaint device was not returned to j&j medtech orthopaedics, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device lot number (214l007), and no non-conformances related to the reported complaint condition were identified.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and 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.
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: investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual inspection found that fastin rc 5mm ocord w/o ndls had the anchor, suture and the inserter still assembled returned for evaluation.Foreign matter, presumably biological matter could be observed on the shaft and proximal end of the anchor.Neither of the devices had any anomaly.A functional testing to disassemble the anchor was performed, when trying to disassemble the implant it was unable to be removed from the inserter.The overall complaint was confirmed as the observed condition of the fastin rc 5mm ocord w/o ndls would contribute to the complained device issue.¿ based on the investigation findings, the potential cause can be traced to the procedural variables, such handling of the device or product interaction during procedure such as: it is possible that bending force was applied to the inserter while insertion, the bending caused the anchor to become jammed, 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 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 record review was performed which indicated that there was a non-conformance unrelated to the reported malfunction.All the issues identified were resolved prior to product release.

• 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 02767 ; 3035526892
• MDR Report Key: 20588787
• Report Number: 1221934-2024-03910
• Device Sequence Number: 21033835
• Product Code: HWC
• UDI-Device Identifier: 10886705008711
• UDI-Public: (01)10886705008711(10)214L007(17)261031
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/01/2024

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
• Device Lot Number: 214L007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/26/2024; 01/13/2025; 01/29/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/27/2024; 01/21/2025; 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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