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

Catalog Number	71692814
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during drilling the most distal screw hole (the first hole from the distal end of the nail), an error message was displayed and disappeared continuously.Then despite targeting the hole on the screen, drilling the hole was not successful (it was drilled out of screw hole).An rld was used to drill two holes (the first and third hole from the distal end of the nail) and complete the procedure.The surgery was delayed for 15 minutes.
Additional Manufacturer Narrative
Only the probe was returned.The sureshot targeter and the interface unit were not returned.Therefore, a product evaluation could not be peformed on these devices.A visual inspection of the returned product found the device is bent.A functional testing of the probe was performed with the available sureshot targeter and the interface unit indicated that the probe functions as intended.The fact that there was a constant warning message about metal interference popping up means the signal wasn¿t reliable enough for proper targeting accuracy.For troubleshooting suggestions, smith and nephew recommend to use the sureshot user manual 81103554.A review of the manufacturing records for the listed probe did not reveal any deviation from the standard manufacturing processes.In addition, our investigation indicated that a second generation targeter has been released and is available for use.Please reference device 71692851.No clinical supporting documents have been provided for inclusion in the medical assessment.Therefore, no thorough medical assessment can be rendered at this time.No additional actions are being taken at this time; however smith and nephew will continue to monitor for future complaints and investigate further as necessary.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 road; memphis TN 38116
• MDR Report Key: 8401410
• Report Number: 1020279-2019-00987
• Device Sequence Number: 389453
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71692814
• Device Lot Number: 18HK00037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention