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

Catalog Number	71692801
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Perforation (2001); Unspecified Tissue Injury (4559)
Date of Event	08/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a humeral internal fixation, the cable of the sureshot targeter device was noticed to be in poor condition and had cracks.After connecting to the console, a warning of interference appeared in the field.When starting the surgery, the sterility was verified.However, later on, the cable damage was noticed to be damaged, with cracks and exposed sections.In addition, when connecting, the distal section of the cable was noticed to be bent and damaged, making the connection so difficult that the support got contaminated in order to achieve the connection, which increased the infection risk.Once the connection was made, the interference message appeared.Clamps were removed, electrodes were turned off, and the table was unplugged to avoid said interference but it was unsuccessful.Therefore, blockages with the system were not possible to perform.Due to this, the surgery was performed after a significant delay, using manual technique to do the blockages this complication generated more anesthesia time and, due to the interference, caused more x-ray exposure and more perforations.".No further consequences were reported.
Additional Manufacturer Narrative
This complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20166058
• Report Number: 1020279-2024-01789
• Device Sequence Number: 17967129
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2024

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
• Device Catalogue Number: 71692801
• Device Lot Number: ND8295
• 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: 08/12/2024
• Initial Report FDA Received Date: 09/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 16 YR
• Patient Sex: Male