MAUDE Adverse Event Report: SMITH & NEPHEW OLECRANON TI LOCKING; PERI-LOC TI OLECRANON PL 8H L 107MM

Catalog Number 71862908

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Date 06/11/2014

Event Type  Injury  

Event Description

It was reported that surgical time was extended by forty minutes due to the 2.00 mm wire used was stuck in the suture hole of plate.

• Brand Name: OLECRANON TI LOCKING
• Type of Device: PERI-LOC TI OLECRANON PL 8H L 107MM
• Manufacturer (Section D): SMITH & NEPHEW; alemannenstrassse 14; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): SMITH & NEPHEW; alemannenstrassse 14; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: carla samuels ; 1450 brooks road; memphis, TN 38116 ; 9013995076
• MDR Report Key: 3902275
• MDR Text Key: 4543113
• Report Number: 8010764-2014-00027
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Catalogue Number: 71862908
• Device Lot Number: 11HT09568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2014
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention