MAUDE Adverse Event Report: DEPUY MITEK LLC US NG HEALIX ALL-IN-ONE AWL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	222314
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Material Deformation (2976); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the device had the etch marks slightly faded.Worn marks were visible on the device.In addition, the awl had traces of foreign matter near to distal end.Neither the handle nor the shaft shows any anomality.No other anomalies were noted.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 ng healix all-in-one awl would have contributed to the complained issue.¿ based on the investigation findings, the potential cause is traced to end of life.Additionally, the possible root cause for the foreign matter condition can be associated with maintenance and/or sterilization procedures.As per ifu: 1) inspect for damage prior to use.Replace a damaged, worn or bent instrument.Do not attempt to straighten, sharpen or repair.2) end of useful instrument life is generally determined by wear or damage from handling or surgical use.Inspect instruments between uses to verify proper functioning.3) it is the responsibility of the end user to ensure that the cleaning and sterilization is actually performed using appropriate equipment, materials, and personnel to achieve the desired result.Properly handling and¿attention to the approved use of the device diminishes the risk of failure.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.
Event or Problem Description
It was reported that the ng healix all-in-one awl device tap laser line had rubbed off and could not visualize the depth clearly.During in-house engineering evaluation, it was determined that the device had traces of foreign matter near to distal end.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: NG HEALIX ALL-IN-ONE AWL
• 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 ; 3035526892
• MDR Report Key: 23530812
• Report Number: 1221934-2025-04333
• Device Sequence Number: 13308775
• Product Code: LXH
• UDI-Device Identifier: 10886705022458
• UDI-Public: (01)10886705022458(10)1211001
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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 Catalogue Number: 222314
• Device Lot Number: 1211001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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