MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL NAIL CAP SET SCREW 0MM; NAIL, FIXATION, BONE

Catalog Number 71656000

Device Problem Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 08/29/2018

Event Type  malfunction  

Event Description

It was reported that the surgeon requested a cap (0mm) in order to place it after we finished with the locks, assembly was made with the corresponding screwdriver, at the moment of screwing the cap in the nail, the cap was broken in the head, preventing it from being screwed in the nail.In addition to that the screwdriver was stuck in the cap and it could not be removed from it.The doctor decided not to put the cap.

Manufacturer Narrative

The associated complaint device was not returned.A review of complaint history did not reveal additional complaints for the listed device.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: META-NAIL NAIL CAP SET SCREW 0MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7917254
• MDR Text Key: 121999883
• Report Number: 1020279-2018-01988
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010585417
• UDI-Public: 03596010585417
• Combination Product (y/n): N
• PMA/PMN Number: K061019
• 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: 02/27/2019

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: 71656000
• Device Lot Number: 16FM08112
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1