MAUDE Adverse Event Report: DEPUY MITEK LLC US ANTEROMEDIAL FEMORAL AIMER 6.5MM -NS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	254686
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
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 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.Device was used for treatment, not diagnosis.H10 additional narrative: d4: the expiration date is currently unavailable.Investigation summary the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the product code 254686 has the lot number engraved on the shaft as 2204001 and in the label has 2205512.An investigation was performed with the manufacturer with the following result: the label, finished goods number, and the laser marked (engraved) lot number are built using work instruction - manufacturing product identification and traceability where it states that an etched date code (yymmxxx) is permissible.In this instance the photo shows the etched lot number 2204001.Per the same work instruction, batch numbers will be automatically assigned by sap or manually assigned to all raw materials, sub-assemblies and finished goods.Per the same work instruction, logistics maintains batch traceability of raw materials, sub-assemblies and finished goods through labeling or other appropriate methods.This applies to the handling, storage, quarantine and distribution of materials.(b)(4) uses a date code with a 500-serial number (b)(6) for traceability.We assert that the parts, and packaging meet the specifications supplied to us by j&j within the work instruction and we are in conformance.It is the assertion of paragon medical that this is compliant to the work instruction and that there is no discrepancy in our processing and labeling of depuy mitek product.A manufacturing record evaluation was performed for the finished device 2205512 number, and no non-conformance's were identified.The overall complaint was not confirmed as the observed condition of the anteromedial femoral aimer 6.5mm - ns would have not contributed to the complained device issue.Based on the investigation findings, 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 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
This is report 2 of 5 for (b)(4).It was reported from china that the lot number on the label on the anteromedial femoral aimer 6.5mm device was not consistent with the lot number that was etched on it.This event did not occur during surgery.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information was provided.

• Brand Name: ANTEROMEDIAL FEMORAL AIMER 6.5MM -NS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 20220932
• Report Number: 1221934-2024-03204
• Device Sequence Number: 7328691
• Product Code: LXH
• UDI-Device Identifier: 10886705013678
• UDI-Public: (01)10886705013678(10)2205512
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 254686
• Device Lot Number: 2205512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 09/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown