MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 10 X 38 130 D TAN RT ROSE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71648238
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a surgery was delayed by more than 30 minutes due to misalignment of the screws.
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).

• Brand Name: 10 X 38 130 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: 6530866
• Report Number: 1020279-2017-00306
• Device Sequence Number: 10963133
• Product Code: HSB
• UDI-Device Identifier: 03596010501158
• UDI-Public: 03596010501158
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K040462
• 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): 09/28/2017

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: 04/30/2026
• Device Catalogue Number: 71648238
• Device Lot Number: 16EM00831
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: 03/01/2017
• Initial Report FDA Received Date: 04/28/2017
• 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
• Outcome Attributed to Adverse Event: Hospitalization