MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 10 X 46 130 D TAN LT LIME; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71647246
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to hypertrophic callus formation resulting in mal/non union.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.A review of complaint history revealed no prior complaints for the listed lot.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Our clinical/medical team noted insufficient clinically relevant documentation was provided, therefore, a thorough medical investigation could not be performed.However, per complaint, the hypertrophic callus formation resulted in a mal/non-union after approximately 1.5 years which required revision.The provided unidentified/undated radiological image supports the reported non-union.No comparison images were provided for md review.The patient impact beyond the revision procedure cannot be determined.No further medical assessment is warranted at this time.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: 10 X 46 130 D TAN LT LIME
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7756529
• Report Number: 1020279-2018-01482
• Device Sequence Number: 1204330
• Product Code: HSB
• UDI-Device Identifier: 03596010500861
• UDI-Public: 03596010500861
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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 Expiration Date: 06/28/2014
• Device Catalogue Number: 71647246
• Device Lot Number: 04FM16359
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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; Required Intervention
• Patient Age: 47 YR