MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN HUMERAL NAIL INSTRUMENT SET; NAIL, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 08/27/2018

Event Type  malfunction  

Event Description

It was reported that during surgery, after the nail was connected to the drill guide, drill got to out of the distal screw hole.Distal screw was ob.The operation was completed with freehand technique with 30 minutes delay.The device will be returned for evaluation.

Manufacturer Narrative

The associated complaint device was not returned.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: TRIGEN HUMERAL NAIL INSTRUMENT SET
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7899536
• MDR Text Key: 121440506
• Report Number: 1020279-2018-01879
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/27/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1