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

Catalog Number 71700005

Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528); Device Damaged Prior to Use (2284)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

Problem with surgeon being unable to place the distal interlocking screws has been reported under mdr 1020279-2017-00286.

Event Description

It was reported that the internal threads for impactor/extractor were stripped prevented surgeon from being able to remove the nail after it was inserted.Surgeon wanted to explant the nail due to previous failure to place the distal interlocking screws and when he was unable to explant the nail it was decided to leave the nail in place without the screws.

• Brand Name: HFN DRILL GUIDE
• 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: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6511155
• MDR Text Key: 73614334
• Report Number: 1020279-2017-00288
• Device Sequence Number: 1
• Product Code: HSB
• 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: 05/26/2017

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: 71700005
• Device Lot Number: 06MSP0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2017
• 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