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	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation anticipated, but not yet begun.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, before an internal fixation surgery, it was noticed that the distal holes of one (1) prox str humeral nail 8/7 x 16 were missing.The procedure was performed, without any delay, using a similar s+n back-up product.No further complications were reported.

• 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: 24707072
• Report Number: 1020279-2026-00416
• Device Sequence Number: 18653495
• Product Code: HSB
• UDI-Device Identifier: 03596010514394
• UDI-Public: 3596010514394
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/09/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• 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: 06/05/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 98629
• Patient Sequence Number: 1
• Patient Sex: Unknown