MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5X26 125D RT; NAIL, FIXATION, BONE

Model Number	71676546
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	09/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the revision was performed due to pain and broken the product.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.[(b)(4)].

• Brand Name: INTERTAN 1.5 11.5X26 125D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6894750
• Report Number: 1020279-2017-00805
• Device Sequence Number: 19037477
• Product Code: JDS
• UDI-Device Identifier: 00885556038055
• UDI-Public: (01)00885556038055(17)260514(10)16EM11975
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2018

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: No Information
• Device Expiration Date: 05/14/2026
• Device Model Number: 71676546
• Device Catalogue Number: 71676546
• Device Lot Number: 16EM11975
• Initial Date Received by Manufacturer: 09/15/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 02/02/2018
• 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: 85 YR
• Patient Weight: 75