MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROX STR HUMERAL NAIL 8/7 X 16; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71760816
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an internal fixation surgery, the prox str humeral nail 8/7 x 16 had no holes for screws in the nail.The procedure was resumed, without any delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
H7: the reported event resulted in a field action.H3, h6: the device, could not be returned for evaluation.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.However, a review made by the quality engineering team revealed that the machinist did not machine the distal holes in accordance with the router step and did not perform inspection per the inspection drawing.The final inspector also failed to identify the nonconformity.Actions have been implemented and will be further executed to prevent recurrence.A review of complaint history based on the historical data revealed a similar event for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.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.According to the drawing print, the device should have two distal holes.Besides, according to the inspection drawing, there is a mill - machine flats / distal holes inspection that verifies part configuration per print; also, the size, distance and hole position.At this time, we have evidence to conclude that the product failed to meet specifications at the time of manufacture.The root cause of this event was determined to be the failure to machine the distal holes and identify the nonconformity.Based on this investigation, the need for corrective action is 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: PROX STR HUMERAL NAIL 8/7 X 16
• 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: 24717825
• Report Number: 1020279-2026-00418
• Device Sequence Number: 12203338
• Product Code: HSB
• UDI-Device Identifier: 03596010514394
• UDI-Public: 3596010514394
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K210980
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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: 71760816
• Device Lot Number: 25BM03616
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown