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

Catalog Number	71692814
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the wrong type of probe was ordered by sales rep's misunderstanding for trigen meta-tan surgery.During operation, the nail and the probe was inserted and then the probe was connected to sureshot system.The monitor displayed only tibial nail, so the mistake was found.Using radiolucent drill, the surgery was completed.No harm to patient, 15 minutes delay.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms a review of this complaint case revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.Possible probable cause could include but not limited the user error.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• 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: 10080862
• Report Number: 1020279-2020-01831
• Device Sequence Number: 19781228
• Product Code: OLO
• UDI-Device Identifier: 03596010648143
• UDI-Public: 3596010648143
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71692814
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71631110; 71692810
• Outcome Attributed to Adverse Event: Required Intervention