MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 11.5MM X 40CM LEFT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71649740
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon taking final xrays it was noticed on the lateral that the screws had split apart and almost looked like they are overlapping.The surgeon tried to take the screw out and reinsert but was not successful.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: META-TAN 11.5MM X 40CM LEFT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6601237
• Report Number: 1020279-2017-00378
• Device Sequence Number: 369414
• Product Code: HSB
• UDI-Device Identifier: 00885556340899
• UDI-Public: 00885556340899
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

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: 71649740
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/31/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1