MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT PERC TAN/FAN DRILL GUIDE PROBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71692815
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during an internal fixation surgery, a sureshot perc tan/fan drill guide probe was opened and connected to the trauma interface, but it did not work, the interface displayed the following error in red color: ¿sureshot probe invalid or broken sensor¿.Surgery was resumed, without any delay, with a back-up device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures was reviewed, and it confirms that the trauma interface didn't recognize the probe.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 complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Damage from misuse, rough handling, a broken wire in the probe cable, bent pins in the connector or an open circuit on the data line are likely probable causes of the reported event.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: SURESHOT PERC TAN/FAN DRILL GUIDE PROBE
• 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: 12367527
• Report Number: 1020279-2021-06503
• Device Sequence Number: 11866787
• Product Code: OLO
• UDI-Device Identifier: 03596010648150
• UDI-Public: 03596010648150
• Combination Product (Y/N): N
• PMA/510(K) Number: K100107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/10/2022

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 Model Number: 71692815
• Device Catalogue Number: 71692815
• Device Lot Number: 20CK00042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/08/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 06/07/2022
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 09/23/2021; 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown