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

Catalog Number	71692801
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that, during the procedure using a sureshot targeter, the donut was connected to the monitor and a red message appeared saying: "sureshot addresser - tool invalid or broken.Replace it".The monitor was then turned off and on, the donut was disconnected, and then reconnected, but the same red message continued to appear.The surgery was completed, after a significant delay, changing the surgical technique, as the blockade was done freehand.No injuries were reported.
Additional Manufacturer Narrative
Sections b5 and d4 were updated.Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during the procedure using a sureshot targeter, the donut was connected to the monitor and a red message appeared saying: "sureshot addresser - tool invalid or broken.Replace it".The monitor was then turned off and on, the donut was disconnected, and then reconnected, but the same red message continued to appear.The surgery was completed, after a significant delay, changing the surgical technique, as a short 4.0 drill bit was used and distal locking was performed freehand.A 4.0 drill bit was inserted, and several x-rays were taken to view the nail hole and allow the drill bit to be inserted.No injuries were reported.
Additional Manufacturer Narrative
H3, h6: this complaint subject is the sureshot targeter software; therefore, no devices will be returned for evaluation.A visual inspection of the image provided was performed and revealed that there could be loose/broken wires or other issues.It is impossible for us to know the root cause without further information.The customer followed the correct procedures according to the troubleshooting section of the user manual (pg.24).Please see sme input in attachments.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed part number, this failure mode will be monitored for future complaints for any necessary corrective actions.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 suspect that the software failed to meet any specifications when it was launched.Factors that could contribute to the reported event include software not programmed correctly, software not updated, connection or mechanical issues.Based on this investigation, the need for corrective action is not indicated.Should 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
• Common Device Name: 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22023891
• Report Number: 1020279-2025-00869
• Device Sequence Number: 7135939
• Product Code: OLO
• UDI-Device Identifier: 03596010648167
• UDI-Public: 3596010648167
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71692801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 06/20/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 05/22/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male