MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INT HEX CAP SCR 5.0MM X 60MM; NAIL, FIXATION, BONE

Model Number	71642260
Medical Device Problem Codes	Fracture (1260); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994); Injury (2348)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was perfomed due to proximal screw breaking after three months of original implant.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.Please see attached for summary for our investigation.(b)(4).
Event or Problem Description
Based on the available information, the revision surgery has not been performed as of this date.
Additional Manufacturer Narrative
[(b)(4)].

• Brand Name: INT HEX CAP SCR 5.0MM X 60MM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6819964
• Report Number: 1020279-2017-00658
• Device Sequence Number: 68611
• Product Code: JDS
• UDI-Device Identifier: 03596010465047
• UDI-Public: (01)03596010465047(17)260105(10)16AM04091
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K981529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/21/2018

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: 01/05/2026
• Device Model Number: 71642260
• Device Catalogue Number: 71642260
• Device Lot Number: 16AM04091
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 07/31/2017; 07/31/2017
• Initial Report FDA Received Date: 08/25/2017
• Supplement Report FDA Received Date: 01/12/2018; 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71642255/10CM17147
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR