MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM LCK TUBULAR PL 6H 82MM; PLATE, FIXATION, BONE

Catalog Number	71809006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after surgery the ulna plate broke.No delay, injury or back up reported.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that this event had already been reported under report no.1020279-2018-02296.

• Brand Name: 3.5MM LCK TUBULAR PL 6H 82MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8017295
• Report Number: 1020279-2018-02292
• Device Sequence Number: 1368584
• Product Code: HRS
• UDI-Device Identifier: 03596010523211
• UDI-Public: 03596010523211
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K033669
• 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): 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71809006
• Device Lot Number: 17LT94828
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 11/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1