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

Catalog Number	71656000
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7917254
• Report Number: 1020279-2018-01988
• Device Sequence Number: 2269868
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 06/08/2026
• Device Catalogue Number: 71656000
• Device Lot Number: 16FM08112
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1