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

Model Number	71692851
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that during surgery the solenoid did not detect the exact hole during use.There was a delay greater than 30 min.No back up applicable for this event since surgeon completed the procedure without the device.No injuries or other complications reported at this time.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that, the information provided is insufficient to determine the root cause of the failure to align.However, based on the information provided, the surgeon completed the procedure without the device because a backup device was not available with a greater than 30-minute delay.Since there were no injuries or other complications reported, no further clinical/medical assessment is warranted at this time.A complaint history review found related failures for the listed device; this failure mode will be monitored for future complaints for any necessary corrective actions.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 risk management file revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible probable causes could include but not limited to probe not inserted correctly/damaged, software not updated, connection or mechanical issues.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device 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.Additional information: d3.

• Brand Name: SURESHOT TARGETER - 2ND GENERATION
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11124408
• Report Number: 1020279-2021-00138
• Device Sequence Number: 10945076
• Product Code: OLO
• UDI-Device Identifier: 00885556584620
• UDI-Public: 00885556584620
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K180277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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: 71692851
• Device Catalogue Number: 71692851
• Device Lot Number: ND7414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1