MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT TARGETER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 71692801

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

Event Type  malfunction  

Event Description

It was reported that during a tibial shaft fracture surgery, the information on the monitor showed " the targeter is invalid or broken, please exchange." finally, the c- arm was utilized to complete the surgery.No more information was available.

Manufacturer Narrative

It was reported that during a tibial shaft fracture surgery, the information on the monitor showed "the targeter is invalid or broken, please exchange." the affected sureshot targeter was returned for evaluation.Visual inspection of the returned product found no obvious signs of damage on the part.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A functional evaluation was performed by connecting the sureshot targeter to the sureshot interface unit.An error message was displayed which read, ¿sureshot targeter invalid or broken tool please exchange.¿ thus, the stated failure was confirmed.The sureshot targeter is a reusable device that can be exposed to numerous surgeries; damage from repeated use can occur.Our investigation found that an upgrade to the targeter has taken place.A second generation targeter has been released and is available for use.Please reference device (b)(4) when replenishing.The device user manual is available, identifying pre-operative requirements for use and troubleshooting suggestions if needed.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: SURESHOT TARGETER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9183915
• MDR Text Key: 162481031
• Report Number: 1020279-2019-03628
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K092497
• 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: 12/23/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71692801
• Device Lot Number: ND4486
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 12/15/2019
• Supplement Dates FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 67