MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL GUIDE HANDLE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71674001

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 04/16/2018

Event Type  Injury  

Event Description

It was reported that the long drill is not going through the distal screw hole, instead the drill is going posterior to the nail.The surgeon had to perform a perfect circles technique to complete the procedure.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.For part: 71674001: a visual inspection confirms that one device shows epoxy flaking inside profile and some dents and scratches.These devices are connecting with mating device without issue.At this time, we are unable to confirm stated failure of these devices.A clinical evaluation was completed for part number 7167001 & this compliant reports an intra-operative implant to implant connection malfunction.During the procedure the surgeon reported, ¿a conversion from the standard surgical procedure to a perfect circles technique to freehand lock the distal hole which prolonged the surgical procedure a little (the length of the delay is unknown)¿.According to the surgeon, ¿there was no patient injury from this¿.The associated implants were returned and evaluated.However, the device analysis did not indicate any mal-performance of the smith and nephew devices.Since there was no alleged harm to the patient, no further clinical/medical investigation warranted at this time.A review of complaint history on the listed parts revealed no prior complaints for the listed batches with the same failure mode.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.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.We consider this investigation closed.

• Brand Name: DRILL GUIDE HANDLE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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 ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 7563878
• MDR Text Key: 109879920
• Report Number: 1020279-2018-01027
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010560469
• UDI-Public: 03596010560469
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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: 71674001
• Device Lot Number: 07CGT0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 06/02/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2007
• 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