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

Catalog Number 71692802

Device Problem Calibration Problem (2890)

Patient Problem Injury (2348)

Event Date 04/03/2017

Event Type  Injury  

Event Description

It was reported that one of the screws inserted on the patient's bone missed the nail hole and was not attached to the nail.

Manufacturer Narrative

The associated trauma interface was returned for evaluation and the sureshot targeter was not returned.Our investigation included an analysis from the manufacturer which indicated no hardware problem found on the interface.All functional tests were performed and it was noted the device functions as intended.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history revealed no prior complaints for the same failure on the listed batch.A clinical evaluation noted that all documents provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.A final operative x-ray was provided, which confirms that the screw is not inside the distal locking hole of the nail.The other distal screw does appear to be through the nail so only one is currently in the distal nail.Since no patient harm or injury is being reported at this time as a result of the extended surgery time and the procedure was completed, no further clinical assessment is warranted.No further actions are being taken at this time; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: TRAUMA INTERFACE
• 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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7262345
• MDR Text Key: 99762030
• Report Number: 1020279-2018-00143
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K170280
• 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
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71692802
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2018
• 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): Other