MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SURESHOT TRAUMA INTERFACE; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 71692802

Device Problem Failure to Align (2522)

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

Event Date 10/04/2017

Event Type  Injury  

Event Description

It was reported a delay during surgery since the targeting device was not correct.On x-ray the drill was superior to the hole in the nail, even though the monitor of the targeting device had it lined up perfectly.

Manufacturer Narrative

Checking boxes in h2.Since they were not cheked in report 1020279-2017-00886 follow-up 001.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.A visual inspection of the products revealed the received probe was broken and the target shows no visible damage.A quality analysis concluded the target calibration is accurate, this was verified via the ¿target accuracy check¿ feature in the software along with a functional probe and instruments and the probe was found to be within the specifications per calibration data and memory chip serial number.A review of complaint history on the listed part revealed no additional complaints for this failure mode with the same batch number.A clinical evaluation indicated that no patient harm or injury is reported as a result of this device related incident, aside from the extended surgery time.No further clinical assessment is warranted based on the information provided.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: SURESHOT TRAUMA INTERFACE
• Type of Device: NEUROLOGICAL 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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6961796
• MDR Text Key: 89729250
• Report Number: 1020279-2017-00886
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K043536
• 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,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71692802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization