MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GUIDE PIN 230MM X 2.4MM; PLATE, FIXATION, BONE

Catalog Number	410236
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during during a percutaneous pinning of an acetabulum, the tip of a 2.4mm guide wire broke off and was retained in the patient.Also, a 7.3mm cannulated screw missed the vertebral body and, in turn, was difficult to remove, but was successfully removed with screw removal set.It is unknown how the procedure was completed and how long it was delayed as consequence of this incident.The patient status was unstable.
Additional Manufacturer Narrative
Associated medwatch report numbers: mw5132648, mw5135316, mw5135531, mw5136192.Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, as of the date of this medical investigation, further clinical documentation could not be sourced as it was noted that the reporter has been undisclosed via medwatch report.Therefore, there were no clinical factors identified which would have contributed to the reported event.The guide pin is an external communicating device made of astm f138 stainless steel, that is neither manufactured nor intended for implantation and should have limited tissue/bone contact as long-term implantation data is not available.The patient impact beyond the retained tip could not be definitively concluded.However, since the tip was not removed, the potential for micromotion/or migration and local tissue inflammation and/or pain could not be ruled out.No further clinical assessment can be rendered at this time.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for care, maintenance, cleaning, and sterilization of smith & nephew orthopedics devices for single-use devices revealed that as the devices are sold both nonsterile and sterile and often removed from their original packaging to be placed in a containment device they should be cleaned and/or inspected prior to sterilization.The device should not be reprocessed or reused if comes in contact with blood, tissue or bodily fluids.Reuse may increase the risk of breakage, failure, patient infection, patient injury and revision surgery.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 reason to suspect 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.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.

• Brand Name: GUIDE PIN 230MM X 2.4MM
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 17861762
• Report Number: 1020279-2023-01882
• Device Sequence Number: 5729964
• Product Code: HRS
• UDI-Device Identifier: 03596010121646
• UDI-Public: 03596010121646
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

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: 410236
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown