MAUDE Adverse Event Report: OSTEOMED INTER-PHALANGEAL STERILE SURGICAL KIT; INTERPHLEX FLEXIBLE STABILITY RODS

Model Number 360-2245

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Information (3190)

Event Date 08/18/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, an expired lot of interphlex interphalangeal rod 4.5mm, lot 1034168 was implanted into the patient.The discrepancy was identified by the operation room manager while reviewing the patient file on the morning of (b)(6) 2014.This lot was manufactured by osteomed may 2010, and shipped to the surgery facility on (b)(4) 2010.The expiration date for this lot, as printed on the package, is 2014-05.

Manufacturer Narrative

The results of the investigation did not identify any product non-conformance.The product was used past the expiration date printed on the label.The exact root cause for use of expired product is unknown.No information was provided as to the explant of the product.Qa note: during an audit of mdr submissions, we identified that the follow up for this report was inadvertently not submitted.

• Brand Name: INTER-PHALANGEAL STERILE SURGICAL KIT
• Type of Device: INTERPHLEX FLEXIBLE STABILITY RODS
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• Manufacturer (Section G): OSTEOMED; 3885 arapaho road; addison TX 75001
• Manufacturer Contact: latoia phillips ; 3885 arapaho road; addison, TX 75001 ; 9726774743
• MDR Report Key: 4036782
• MDR Text Key: 18922938
• Report Number: 2027754-2014-00009
• Device Sequence Number: 1
• Product Code: KWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2014
• Device Model Number: 360-2245
• Device Catalogue Number: 360-2245
• Device Lot Number: 1034168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 20 YR