MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MEDIUM HEXDRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71631066
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an internal fixation surgery, the tip of the medium hexdriver broke an remains inside the screw head in the patient body.There is no plan to additional surgery to remove the piece as the patient is old.The procedure was resumed using the same device.No further consequences were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed the threads (tip) of the internal shaft broke off, the shaft is stuck inside the external hexdriver and cannot be removed.The broken piece of the threads was not returned.The device shows signs of extensive wear and use.The clinical/medical investigation concluded that, based on the information provided, an user error cannot be ruled out as the likely cause of the reported adverse event.The non-implantable tip of the medium hexdriver remains inside the implantable screw head inside the patient.It was not reported if the broken tip inside of the screw was secured.Therefore, we cannot rule out the possibility of micro-motion and/or migration, pain, and skin irritation.Although, we cannot determine the impact of the non-implantable foreign body.No other complications were reported.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 device over 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: MEDIUM HEXDRIVER
• 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: 18450207
• Report Number: 1020279-2024-00018
• Device Sequence Number: 7033945
• Product Code: HSB
• UDI-Device Identifier: 03596010478443
• UDI-Public: 03596010478443
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: 21CM16493
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female