MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN DRILL GUIDE EXTENDED; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71934690

Device Problems Fracture (1260); Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported that during surgery one (1) extended guide bolt was cross threaded onto the nail through one (1) intertan drill guide extended and it was not possible to remove the bolt from the nail.It seems the instrument fractured off due to this problem.It is unknown if pieces fell into the patient.The procedure was resumed, after a delay greater than 30 min, with an unspecified change in surgical technique.

Manufacturer Narrative

Internal complaint reference (b)(4).

Manufacturer Narrative

The device was not returned for evaluation.However, the photographs were reviewed, and revealed that the device is fractured.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 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 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: INTERTAN DRILL GUIDE EXTENDED
• Type of Device: 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: 18915217
• MDR Text Key: 337797348
• Report Number: 1020279-2024-00537
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556266441
• UDI-Public: 885556266441
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71934690
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EXT GDE BOLT (PN: 71934691)