MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 61MM; REAMERS

Catalog Number	244000561
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary according to the information received, it was reported that graters were dull.The issue did not happen in surgery.The product was returned to j&j medtech orthopedics' for evaluation.Visual analysis of the device found rounding of cutting edges.It is not unreasonable that the condition identified in visual analysis would contribute to a dull condition.Therefore, we are able to confirm dullness with damage observed, as this kind of evidence indicates repeated use of the device.Additionally to the consistent damage exhibited on device, corrosion patterns was found outside of the cutting surface.Where corrosion/oxidation is identified around the cutting surface of the device, alongside damage consistent with normal wear, this suggests that the passive layer of the metal has been worn down from repeated use (due to normal use damage) allowing for the metallic surface underneath to become susceptible to corrosion/oxidation.The lifecycle requirements of the device are event related and depend on the use in clinical practice, 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.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of quickset ace grater head would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of medtech orthopedics' 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 lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that graters were dull.The issue did not happen in surgery.All available information has been disclosed for reporting.No further information was provided.

• Brand Name: QUICKSET ACE GRATER HEAD 61MM
• Common Device Name: REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 21453915
• Report Number: 1818910-2025-03008
• Device Sequence Number: 20632225
• Product Code: HTO
• UDI-Device Identifier: 10603295124085
• UDI-Public: (01)10603295124085(10)SO2005523
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 244000561
• Device Lot Number: SO2005523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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