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

Catalog Number	71631070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference (b)(4).
Event or Problem Description
It was reported that, on (b)(6) 2023 during an internal fixation surgery, the tip of a long hexdriver was noticed to be missing.The same instrument was used in a previous internal fixation procedure on (b)(6) 2023, and when x-rays of the patient were reviewed, it was confirmed the missing piece was left inside the patient, in the distal captured screw head.It is unknown if an additional procedure has been scheduled to retrieve the broken tip.Patient's current health status is unknown.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the hexdriver shaft portion of the device threaded tip was broken off.The broken piece and the long hexdriver portion of the device were not returned.The clinical/medical investigation concluded that human error with non-adherence to the instructions for use was likely the contributing factor to the reported event as the instrument was being used on another patient (¿b¿) in non-working condition and the fractured tip was reportedly noted in the post-operative imaging of the patient (¿a¿) who underwent a similar procedure the previous week.The patient impact includes the reported non-implantable (hex driver tip/fragment) foreign body retained/embedded in the distal captured screw head.Although it is unlikely; micro-motion, corrosion, and/or discomfort cannot be definitively ruled out.No delay or further patient injury was reported due to this issue, as this was noted only in the post-operative imaging a week later.It is unknown if there are plans to retrieve the foreign body or if there are other planned interventions due to the reported event.The material composition would be custom 465 stainless steel based on the complaint description of a fractured hex driver-tip which is manufactured and intended for short-term tissue contact; therefore, no long-term implantation data is available.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 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, rough handling or human error 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: LONG 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: 18544427
• Report Number: 1020279-2024-00186
• Device Sequence Number: 15682202
• Product Code: HSB
• UDI-Device Identifier: 03596010519269
• UDI-Public: 03596010519269
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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: 71631070
• Device Lot Number: 21AM17609
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown