MAUDE Adverse Event Report: SMITH & NEPHEW, INC. P-L-D HUM LK PL 15H L 207MM; PLATE, FIXATION, BONE

Catalog Number	71802615
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	06/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the fixation plate broken shortly after being implanted.

• Brand Name: P-L-D HUM LK PL 15H L 207MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6758256
• Report Number: 1020279-2017-00575
• Device Sequence Number: 13732235
• Product Code: HRS
• UDI-Device Identifier: 03596010574466
• UDI-Public: 03596010574466
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K061352
• 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
• Report Date (Section B): 08/01/2017

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: 07/09/2018
• Device Catalogue Number: 71802615
• Device Lot Number: 13GM05806
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 08/01/2017
• 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; Required Intervention