MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HUMERAL NAIL 8/7MM X 24CM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71770824
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Unspecified Tissue Injury (4559); Periprosthetic fracture (4902)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication reported that includes reference to the use of a smith+nephew product without evidence about a specific product problem.The reported complication relates to known inherent 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 confirm a relationship between the reported event and the device or 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 submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alter the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during a humeral internal fixation surgery, the doctor began reaming with the 6mm reamer, then he switches to the 8mm reamer, it was not reaming the totality of the canal, only a couple of millimeters below the line of the fracture, because the bone is showing resistance.He then goes back to the 7mm reamer, but it also does not ream the totality of the canal.He proceeds to implant the humeral nail 8/7mm x 24cm, but the insertion is difficult and the fracture began to open.The surgeon attempts to hammer the nail out.While doing so, he fractured a humeral guide bolt wrench and deformed the humeral nail drill guide.Since it was not possible to extract the nail, the surgeon decided to force the nail which fractured the most distal anterior part of the bone.He proceeded to make the distal and superior blockage.The procedure was completed with the same nail and delayed 45 minutes, therefore required 45 minutes of additional anesthesia.Current health status of the patient is stable.
Additional Manufacturer Narrative
H3, h6: given the nature of the alleged incident, the device could not be returned for evaluation.The clinical/medical investigation concluded that, the provided intra-op fluoroscopy images do appear to support the complaint with the proximal nail appearing to be seated below the articular surface in the presence of a distracted humeral fracture.Pre- and/or post-op images were not provided for comparison.The surgical technique notes ¿additional limited reaming is necessary for proximal nails longer than 8mm x 16cm¿ and ¿note: ensure the nail will be slightly countersunk¿.The instruction for use includes warnings ¿intraoperative fracture or breaking of instruments can occur¿ and ¿improper selection, placement, positioning, and fixation of the implant components may result in unusual stress conditions and subsequent early failure/fracture of the components¿.The reported modified surgical technique including suspected inadequate canal prep/reaming, forceful implantation, and hammering the wrench and drill guide led to the distracted humeral fracture, extended surgery under anesthesia for an additional 45-minutes along with the broken and deformed instrumentation.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: HUMERAL NAIL 8/7MM X 24CM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23450994
• Report Number: 1020279-2025-01816
• Device Sequence Number: 8057106
• Product Code: HSB
• UDI-Device Identifier: 03596010514431
• UDI-Public: 3596010514431
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K032722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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
• Report Date (Section B): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71770824
• Device Lot Number: 24MM06837
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PN: 71751129 / LOT: 16DSP0012; PN: 71751134 / LOT: 15MTF0005
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 62 KG