MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG SCREW INSERTION ASSEMBLY; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71687029
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a surgery was extended by over two hours after the instrument threads stripped.
Additional Manufacturer Narrative
Please review attached for the investigation results.(b)(4).

• Brand Name: LAG SCREW INSERTION ASSEMBLY
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6695122
• Report Number: 1020279-2017-00515
• Device Sequence Number: 1078255
• Product Code: HSB
• UDI-Device Identifier: 03596010518941
• UDI-Public: 03596010518941
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2017

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 Catalogue Number: 71687029
• Device Lot Number: 12ENM0003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2017
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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
• Patient Age: 86 YR