MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERCUTANEOUS GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71631024
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the osteosynthesis procedure, the percutaneous guide bolt fractured, leaving its tip inside the nail that was implanted in the patient.The procedure was resumed, after a non-significant delay, with the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation.However, the photograph was reviewed, and revealed a shortened threaded portion of the guide bolt which confirms the fracture.The clinical/medical investigation concluded that, the adverse event was likely caused partially or wholly by the user of the product as it is the end user¿s responsibility to inspect the instrument prior to use to ensure ¿good working order¿/determine the end of a ¿serviceable life¿ of the device which is used to facilitate the percutaneous drill guide use with the nail.A user technique/procedure variance and/or device wear cannot be ruled out as potential contributing factors.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed a similar event for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of instructions for use for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.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 the device or 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.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed that the proximal end is fractured and the tip was not returned.The device is worn from use.The clinical/medical investigation concluded that, based on the available information, the fracture of the percutaneous guide bolt during the osteosynthesis procedure was likely influenced by user-related factors, such as failure to inspect the instrument prior to use or potential technique variance.While the patient experienced a minor surgical delay, no direct harm was reported.However, the embedded tip of the guide bolt remains within the implanted nail, which could pose challenges if future revision or removal is required.Due to limited documentation and imaging, the possibility of corrosion, micromotion, or migration cannot be entirely ruled out.All provided materials have been reviewed and considered in this assessment.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 instructions for use documents for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.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 device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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: PERCUTANEOUS GUIDE BOLT
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 21586971
• Report Number: 1020279-2025-00466
• Device Sequence Number: 18332190
• Product Code: HSB
• UDI-Device Identifier: 03596010604903
• UDI-Public: 3596010604903
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K122170
• 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): 08/08/2025

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: 71631024
• Device Lot Number: UNKNOWN
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 05/09/2025; 08/05/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 05/14/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 75 KG