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

Catalog Number	71656000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the reduction of the fracture was performed without any problem.The nail was passed in the correct way and its distal blocks were made without issues with the sure shot, likewise the proximal ones with the device.When the cap (0 mm ) was placed, this was placed in the correct way and it was pressed into the nail, but when we were checking with the intensifier, we could see that the cap was missing a little more to enter.When the doctor passes the screwdriver, we notice that the cap was broken as 2 lines of the thread, that complete thread was removed by bits and more than half of the cap was inside the nail, without causing problems to the device, or the patient.The surgical procedure was completed without complications.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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: META-NAIL NAIL CAP SET SCREW 0MM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8062090
• Report Number: 1020279-2018-02429
• Device Sequence Number: 16650345
• Product Code: JDS
• UDI-Device Identifier: 03596010585417
• UDI-Public: 03596010585417
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71656000
• Device Lot Number: 17CM02714
• Initial Date Received by Manufacturer: 11/04/2018
• Supplement Date Received by Manufacturer: 11/04/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1