MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5/6.5 HEALIX ADVANCE AW; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	222315
Medical Device Problem Codes	Material Deformation (2976); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
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.H10 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is currently unavailable.Investigation summary = > the product was returned to mitek for evaluation.Mitek then conducted visual inspection and functional test of device received.Upon visual inspection the device showed wear use.It could be observed the tip of the device with a bent condition.Also, it could be identified that the etch marks are slightly faded.Neither the handle nor the shaft shows any anomality.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.Based on the visual inspection results, this complaint can be confirmed.The possible root cause for the condition of the device tip could be related to heavily use; moreover, drop of the unit, mishandling or procedural variables that could cause the bent condition of the device tip.Since this device is reusable, the continuous use and sterilization process can cause worn condition and the fading of the etch marks.However, it cannot be conclusively affirmed.As per ifu, inspect for damage prior to use.Replace a damaged, worn or bent instrument.Do not attempt to straighten, sharpen or repair.Do not use a depuy mitek reusable instrument for any purpose other than its intended use as that may result in damage to the instrument.At this point in time, 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.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep that during an unknown procedure on an unknown date, it was observed that the laser line of the 5.5/6.5 healix advance awl device was very faint and difficult to see for the surgeon.During in-house engineering evaluation, it was determined that the device was deformed/bent.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: 5.5/6.5 HEALIX ADVANCE AW
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 18518058
• Report Number: 1221934-2024-00111
• Device Sequence Number: 7698177
• Product Code: LXH
• UDI-Device Identifier: 10886705022465
• UDI-Public: 10886705022465
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2024

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: 222315
• Device Lot Number: 1205003R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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