MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 1.6MM DRILL TIP WIRE 150MM; PLATE, FIXATION, BONE

Catalog Number 71101502

Device Problems Fracture (1260); Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: case-(b)(4).

Event Description

It was reported that, during open fracture reduction, it was noticed that one (1) 1.6mm drill tip wire 150mm was used to reduce the fracture and use it as a guide to place 2.7mm cortical screws of the vlp foot system, at the moment of trying to reduce the fracture, an exaggerated movement was made overloading the pin and it broke and remained inside the patient.The procedure was resumed, after a non-significant delay, with a s+n back-up device.Patient was not injured as consequence of this problem.

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation; therefore, a device analysis could not be performed.However, the photographs were reviewed and revealed that the threaded end portion of the device fractured off.The clinical/medical investigation concluded that, based on the information provided, the definitive clinical root cause of the reported breakage cannot be determined.However, the reported ¿exaggerated¿ movement could not be ruled out as the likely cause of the reported adverse event.Two fluoroscopic images confirm the broken drill tip within the bone.As this is intraoperative, this does not confirm final location of the drill tip.The retained broken tip is comprised of cobalt chrome; this material may be used for surgical implants and can be considered surgical grade.This is an implantable device.The broken tip was retained in the bone.Therefore, the potential for micro-motion and/or migration is unlikely.The impact to the patient was the retained broken pin and the non-significant surgical delay.Since it was reported the patient was not injured as consequence of this problem, no further clinical/medical assessment is warranted 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 fracture fixation devices revealed in the adverse effects that cracking and fracture of the implant components can occur.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.According with material specification, the quality and manufacture of cobalt-chromium alloy bar, wire and fine wire shall be controlled.This material may be used for surgical implants and the alloy can be considered surgical grade.At this time, we have no evidence to conclude that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected, surgical technique, patient anatomy or excessive forces.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.H6: health effect - impact code.

• Brand Name: 1.6MM DRILL TIP WIRE 150MM
• Type of Device: 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: 18730845
• MDR Text Key: 335719283
• Report Number: 1020279-2024-00388
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010626745
• UDI-Public: 03596010626745
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K090675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 71101502
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/19/2024
• Supplement Dates Manufacturer Received: 04/04/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 70 KG