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

Model Number 71692801

Device Problem Computer Software Problem (1112)

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

Event Date 01/08/2021

Event Type  Injury  

Event Description

It was reported that, the sureshot targeter host computer screen reported an error saying "sureshot targeter invalid or broken tool, please exchange".The procedure was completed by changing the surgical technique.There was a delay less than or equal to 30min.No patient injury or other complications were reported.

Manufacturer Narrative

H3, h6: the device, used in treatment was returned for evaluation.Visual inspection of the returned device displays no signs of wear and tear from use.Functional testing of the returned device confirms that the sureshot targeter when connected to the computer displays error "sureshot targeter invalid or broken tool, please exchange".A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the complaint history for the listed part revealed prior complaints for the part and listed failure mode but no other complaints with the same serial number as this is a unique serial device.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.We recommend that all re-usable instruments be routinely inspected for wear/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 actions are being taken at this time.We consider this investigation closed.

• Brand Name: SURESHOT TARGETER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11250164
• MDR Text Key: 229291461
• Report Number: 1020279-2021-00757
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 03596010648167
• UDI-Public: 03596010648167
• Combination Product (y/n): N
• PMA/PMN Number: K092497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71692801
• Device Catalogue Number: 71692801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention