MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT META STANDARD DRILL GUIDE PROBE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	71692814
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system could not recognize the probe during the surgery, delivering an error message.A delay of 0 to 30 minutes reported.No patient injuries reported.An s&n backup was available.
Additional Manufacturer Narrative
Results of investigation: it was reported that the system could not recognize the probe during the surgery, delivering an error message.A delay of 0 to 30 minutes reported.No patient injuries reported.The associated sureshot drill guide probe, used in treatment, was returned and evaluated.Visual inspection of the returned product found no obvious damage on the part.A review of the manufacturing records for the listed batch number did not reveal any deviation from the standard manufacturing processes.A functional evaluation was performed by connecting the device to the sureshot interface unit which could not confirm the stated failure.The device was recognized by the unit and it functioned as intended.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Some potential causes of the reported event could include but not limited to metal interference or connection issue.It should be noted that the probe is not reusable.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Based on the information provided no corrective action is indicated.No additional actions are being taken at this time; however we will continue to monitor for future complaints and investigate further as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: SURESHOT META STANDARD DRILL GUIDE PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10411792
• Report Number: 1020279-2020-03952
• Device Sequence Number: 2552748
• Product Code: OLO
• UDI-Device Identifier: 03596010648143
• UDI-Public: 03596010648143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092497
• 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): 11/19/2020

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: 71692814
• Device Catalogue Number: 71692814
• Device Lot Number: 19LK00035
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 08/15/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1