MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 10 X 34 130 D TAN RT ROSE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71648234
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a broken nail.
Additional Manufacturer Narrative
The associated trochanteric antegrade nail was not returned for evaluation.Therefore, a product analysis could not be conducted.However, device details were provided.Thus, our investigation including the manufacturing records and complaint history review was conducted.The review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation warranted for this complaint; and smith and nephew will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: 10 X 34 130 D TAN RT ROSE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8384275
• Report Number: 1020279-2019-00890
• Device Sequence Number: 11260257
• Product Code: HSB
• UDI-Device Identifier: 03596010501134
• UDI-Public: 03596010501134
• Combination Product (Y/N): N
• PMA/510(K) Number: K040462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 06/29/2026
• Device Catalogue Number: 71648234
• Device Lot Number: 16GM00720
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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