MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 6.00MM FXD ENDCUTTING RMR; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Catalog Number	71118220
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during a nail reaming procedure one (1) 6.00mm fxd endcutting rmr became lodged in the patient's bone canal.Despite efforts to dislodge it, the surgeon decided to proceed with plating as the canal could not be prepared for the thinnest 8/7mm humeral nail.While waiting for the plating instruments and kits to arrive, the surgeon compared the 6.00mm fxd endcutting rmr with the 7.00mm fixed end-cutting reamer and observed that the former appeared thicker.The surgeon then attempted to use the 7.00mm fixed end-cutting reamer, which passed through the bone canal without difficulty.The procedure was resumed, after a significant delay with the insertion of the 8/7mm humeral nail.Upon return of the 6.00mm fxd endcutting rmr to the osc, the reamer tip was measured and found to be 8mm.
Additional Manufacturer Narrative
Internal reference number: (b)(4).

• Brand Name: 6.00MM FXD ENDCUTTING RMR
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20165937
• Report Number: 1020279-2024-01787
• Device Sequence Number: 7363540
• Product Code: JDG
• UDI-Device Identifier: 03596010436535
• UDI-Public: 3596010436535
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2026

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: 71118220
• Device Lot Number: 19HM05311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: Not provided; 06/19/2026
• Initial Report FDA Received Date: 09/08/2024
• Supplement Report FDA Received Date: 03/02/2026; 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown