MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STERILE 6.4MM DRILL; PLATE, FIXATION, BONE

Catalog Number	71631035
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intramedullary nailing procedure, due to the patient's bone being very rigid and dense, one (1) sterile 6.4 mm drill broke during reaming.The broken pieces were completely removed with forceps.The procedure was completed without delay using the same device.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).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 investigative findings or information becomes available that alter the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4).Additional information: e1 correction: h5.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H11: the associated device was returned and evaluated.The visual inspection revealed that the device returned wear from use.The distal tip of the drill is fractured off and was not returned.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 revealed a similar event for the listed part number over the previous 12 months, but no similar events for the batch based on the historical data, 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.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.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.

• Brand Name: STERILE 6.4MM DRILL
• Common Device Name: PLATE, FIXATION, BONE
• 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: 23657145
• Report Number: 1020279-2025-01953
• Device Sequence Number: 4824701
• Product Code: HRS
• UDI-Device Identifier: 03596010605962
• UDI-Public: 3596010605962
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2026

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: 71631035
• Device Lot Number: 17MNG0018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 03/31/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/29/2025; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2018
• 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 Age: 36 YR
• Patient Sex: Female