MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT TARGETER - 2ND GENERATION; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 71692851

Device Problem Imprecision (1307)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that, during an internal fixation procedure, when drilling using one (1) sure shot targeter - 2nd generation, both the red and the green ring were fully within the the hole of the model-nail on display.However, the actual drill did not target the screw on the actual nail.The procedure was resumed, after a non-significant (10 min) delay, by changing in radiolucent drill.Patient was not harmed as a consequence of this problem.

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Manufacturer Narrative

H3, h6: the devices were not returned for evaluation; therefore, a device analysis could not be performed.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.For the sureshot targeter, a review of complaint history revealed a similar event for the listed device over the previous 12 months.No other complaints with the same serial number, as this is a unique serial device.For the trauma interface, a review of complaint history did not reveal similar events for the listed device over the previous 12 months.No other complaints with the same serial number, as this is a unique serial device.This failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management files 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 these products and event.At this time, we have no evidence to conclude that the products failed to meet any specifications at the time of manufacture.This devices are reusable instruments that can be exposed to numerous surgeries.Damage from prolonged use, connection issues, broken wire in a cable, a damaged connector or sensor, software not programmed correctly or software not updated 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 devices 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: SURESHOT TARGETER - 2ND GENERATION
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 18769252
• MDR Text Key: 336534817
• Report Number: 1020279-2024-00429
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556584620
• UDI-Public: 00885556584620
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K180277
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71692851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• 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: TRM INTERFACE(PN:71692852,SN:(B)(6).