MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM SURESHOT SHORT DRILL SLEEVE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 71692805

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Date 02/27/2019

Event Type  Injury  

Event Description

It was reported that when trying to target the medial and lateral holes, doctor was off by a couple of mm posteriorly, but he managed to get one screw in by over compensating and was too far posteriorly from the second hole and hit the nail.No information about a delay was provided and back-up device was available but the procedure was completed using a freehand technique.

Manufacturer Narrative

The affected sureshot targeter and the sureshot short drill sleeve were returned and evaluated.Our investigation including an engineering analysis noted that both devices target accurately, thus they function as intended.Almost all posterior 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.As device details were provided, a device history records and complaint history review has been performed.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.It is indicated during our investigation that the sureshot targeter has been obsoleted and is no longer available for purchasing.Please reference replacement new targeter (second generation) 71692851 when replenishing.Our clinical evaluation noted that the root cause of the failure is probably user vs procedural event and/or probable bone loss from primary implantation.The impact to the patient beyond bone loss due to drilling cannot be determined.The future impact from the extra hole placed in combination with the noted previous bone loss cannot be concluded.A backup device was available, however, surgeon decided to do free-hand technique to complete the procedure.When having complications with a sureshot device, we encourage you to refer to user manual for trouble shooting suggestions.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: 4.0MM SURESHOT SHORT DRILL SLEEVE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8444329
• MDR Text Key: 139576398
• Report Number: 1020279-2019-01148
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K100107
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/27/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71692805
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 05/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention