MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM LCK COMP PL 12H 183MM; PLATE, FIXATION, BONE

Catalog Number 71829712

Device Problem Bent (1059)

Patient Problem Fracture, Arm (2351)

Event Date 10/30/2014

Event Type  Injury  

Event Description

It was reported that the implant was bent to almost 90 degrees.

Manufacturer Narrative

Please review attached for the investigation results.

• Brand Name: 3.5MM LCK COMP PL 12H 183MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6911296
• MDR Text Key: 88044169
• Report Number: 1020279-2017-00823
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K033669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 71829712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 33 YR