MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 10MM X 38CM; NAIL, FIXATION, BONE

Catalog Number	71655138
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery is scheduled.This is because in or everything went well, but from post-operative pictures it was seen, that the tip of most proximal screw is in the joint.
Additional Manufacturer Narrative
Results of investigation:the associated complaint device was not returned for evaluation.A clinical investigation concluded that based on insufficient information, a clinical assessment cannot be performed at this time.A review of the manufacturing records did not reveal any deviations that could have caused or contributed to the reported incident.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: META-NAIL TIBIAL 10MM X 38CM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7251567
• Report Number: 1020279-2018-00133
• Device Sequence Number: 16363079
• Product Code: JDS
• UDI-Device Identifier: 03596010585608
• UDI-Public: 03596010585608
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Followup
• Report Date (Section B): 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71655138
• Device Lot Number: 17CT83847
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 01/29/2018; 01/29/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 03/07/2018; 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other