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

Model Number	71692801
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11250164
• Report Number: 1020279-2021-00757
• Device Sequence Number: 17039838
• Product Code: OLO
• UDI-Device Identifier: 03596010648167
• UDI-Public: 03596010648167
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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 Model Number: 71692801
• Device Catalogue Number: 71692801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention