MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX CURVE GUIDE FRAME; PIN, FIXATION, SMOOTH

Catalog Number 213004

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2024

Event Type  malfunction  

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.H10 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is unknown.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

It was reported by the sales rep that during an unspecified surgical procedure on an unknown date the rigidfix curve guide frame device had a broken screw in the curve set.It was impossible to use the guide without that screw.In order to resolve the issue, the surgeon used a back-up set.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.

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.H4: the device date of manufacture was unknown in the initial report and has been updated accordingly.Investigation summary: photos were returned to depuy synthes mitek for evaluation.The depuy synthes mitek team conducted a visual inspection of the returned photos.Upon visual inspection of the photos, it was noted that the device screw head is broken, also the device shows marks of wear, no further information was provided.The observed condition was identified as an end of life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the rigidfix curve guide frame would contribute to the complained device issue.Based on the investigation findings, the root cause is traced to end of life.As per the instructions for use; inspect all instruments for damage before use.Do not attempt to repair.It has been determined, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance device history review : a manufacturing record evaluation was performed for the finished device lot number: and no non-conformances were identified.

• Brand Name: RIGIDFIX CURVE GUIDE FRAME
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 18849552
• MDR Text Key: 337101027
• Report Number: 1221934-2024-00747
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 10886705019953
• UDI-Public: 10886705019953
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K130105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 213004
• Device Lot Number: 136725RR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Type of Device Usage: Unknown
• Patient Sequence Number: 1