MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MEDIUM HEXDRIVER; SCREWDRIVER

Catalog Number	71631066
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: 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.
Event or Problem Description
It was reported that, during an internal fixation, the tip of the threaded internal rod of a (1) medium hexdriver snapped off.It was left into the screw in the patient, because it was threaded into the screw and could not be removed.The procedure was resumed, without any delay, using a s+n back-up device.No injury was reported as a consequence of this issue.The patient is recovering well.
Additional Manufacturer Narrative
H2: additional information ¿b5¿.
Event or Problem Description
It was reported that, during an nail internal fixation, the tip of the threaded internal rod of a (1) medium hexdriver snapped off.It was left into the screw in the patient's tibia, because it was threaded into the screw and could not be removed.The procedure was resumed, without any delay, using a s+n back-up device.The patient is recovering well.
Additional Manufacturer Narrative
Corrected data: b1, b2, d9 & h3 (device returned for analysis), h6 (health effect - clinical code, component code, type of investigation, investigation findings, investigation conclusions).Updated results of investigation: the associated device was returned and evaluated.The visual inspection revealed that the device returned wit the distal end fractured off and the remaining threads deformed.The device is scratched, scuffed and discolored from use.The laser markings are faded but legible.The clinical/medical investigation concluded that based on the limited information provided the clinical root cause of the reported breakage could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.This instrument is an externally communicating device, it is neither manufactured nor intended for implantation.Long-term implantation data is not available.The patient impact is determined to be the retained non implantable fragment.Micro-motion or movement is unlikely as it was noted that the retained threaded tip was left within the screw in the patient's tibia; however, there is potential risk for tissue inflammation and/or pain.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 similar events 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 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.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: MEDIUM HEXDRIVER
• Common Device Name: SCREWDRIVER
• 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: 21341203
• Report Number: 1020279-2025-00258
• Device Sequence Number: 9078717
• Product Code: HXX
• UDI-Device Identifier: 03596010478443
• UDI-Public: 3596010478443
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2025

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: 71631066
• Device Lot Number: 11MM03245
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: 04/04/2025; 04/08/2025
• Initial Report FDA Received Date: 02/09/2025
• Supplement Report FDA Received Date: 04/07/2025; 04/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2011
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown