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

Catalog Number	71692815
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the surgeon was using the sureshot with meta-tan nail, and missed the hole twice.Two additional 4.0mm holes were perforated in the patient's femur.There was no backup device available and the procedure was delayed no more than 30 minutes due to the surgeon had to drill the holes using the freehand technique without the sureshot.There is no patient data available to provide for clinical investigation.
Additional Manufacturer Narrative
Only the sureshot targeter was returned and evaluated.The complaint drill guide probe was not returned.Therefore, a product evaluation could not be peformed on this device.Visual inspection of the returned targeter found no obvious signs of damage.A review of the manufacturing records for the listed parts did not reveal any deviation from the standard manufacturing processes.A functional test was performed on the sureshot targeter which noted the device functioned as intended as it was recognized by the inferface unit.As the probe was not made available for evaluation, the stated failure could not be replicated with accuracy.Per the user manual instructions, the presence of certain metal objects within the electromagnetic tracking volume system may cause unexpected or adverse operation.Almost all misses are due to metal interference from the or table or aluminum ¿bump¿ used to position the patient¿s leg.These metal objects ¿pull¿ the electromagnetic signal toward them and skews the targeting.For troubleshooting suggestions, smith and nephew recommend to use the sureshot user manual 81103554.In addition, our investigation indicated that a second generation targeter has been released and is available for use.Please reference device 71692851.Without the return of the actual probe involved and no details information on the surgery itself, our investigation of this report is inconclusive.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.We consider this investigation closed.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
Only the sureshot targeter was returned and evaluated.The complaint drill guide probe was not returned.Therefore, a product evaluation could not be peformed on this device.Visual inspection of the returned targeter found no obvious signs of damage.A review of the manufacturing records for the listed parts did not reveal any deviation from the standard manufacturing processes.A functional test was performed on the sureshot targeter which noted the device functioned as intended as it was recognized by the inferface unit.As the probe was not made available for evaluation, the stated failure could not be replicated with accuracy.Per the user manual instructions, the presence of certain metal objects within the electromagnetic tracking volume system may cause unexpected or adverse operation.Almost all misses are due to metal interference from the or table or aluminum ¿bump¿ used to position the patient¿s leg.These metal objects ¿pull¿ the electromagnetic signal toward them and skews the targeting.A relationship between the device and the reported incident were not corroborated.For troubleshooting suggestions, smith and nephew recommend to use the sureshot user manual 81103554.In addition, our investigation indicated that a second generation targeter has been released and is available for use.Please reference device 71692851.Without the return of the actual probe involved and no details information on the surgery itself, our investigation of this report is inconclusive.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.

• Brand Name: SURESHOT PERC TAN/FAN DRILL GUIDE PROBE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8573261
• Report Number: 1020279-2019-01716
• Device Sequence Number: 16216195
• Product Code: OLO
• UDI-Device Identifier: 03596010648150
• UDI-Public: 03596010648150
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K100107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2019

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: 71692815
• Device Lot Number: 18EK00058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 04/02/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 07/16/2019; 08/01/2019
• 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; Other