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

Catalog Number 71692801

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2018

Event Type  malfunction  

Event Description

Doctors used a femoral nail to treat a patient suffering from a left femoral shaft fracture.Sureshot distal telescope disc failed to sense the distal nail of intramedullary nail and appeared on the monitor.Connect the wrong tip, the doctor then lined the c-arm x-ray lock distal lock!.

Manufacturer Narrative

The associated sureshot targeter was returned and evaluated.A visual inspection of the returned product revealed cosmetic blemishes on the grey and orange silicon overmolding in different locations.A functional evaluation was performed by connecting the sureshot targeter to the sureshot interface unit which recognized the targeter.Therefore, our investigation could not confirm the stated failure.However, this failure mode has been previously identified and the device is currently being redesigned to help reduce/eliminate this issue from recurrence.A review of complaint history for the part revealed no prior complaints for the listed serial number.No additional actions are being taken at this time.However we will continue to monitor for future complaints and investigate further as necessary.When having complications with a sureshot device, we encourage you to refer to user manual 7118-1540 for trouble shooting suggestions.We consider this investigation closed.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
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull hu3 2bn; UK
• MDR Report Key: 7471701
• MDR Text Key: 106845642
• Report Number: 1020279-2018-00831
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

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: Physician
• Device Catalogue Number: 71692801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 04/03/2018
• Supplement Dates FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 65