MAUDE Adverse Event Report: BIOMET ORTHOPEDICS SOLID LAG SCREW REAMER; INSTRUMENT, MANUAL

Model Number N/A

Device Problems Fracture (1260); Component Missing (2306); Device Contamination with Body Fluid (2317); Device Disinfection Or Sterilization Issue (2909)

Patient Problems Cardiac Arrest (1762); Fall (1848); Bone Fracture(s) (1870); Loss of consciousness (2418)

Event Date 12/05/2015

Event Type  Injury  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Device code - unknown; pma/510(k) number/ manufacture date ¿ unknown.

Event Description

It was reported a patient underwent an internal hip fixation procedure on (b)(6) 2015 due to a fracture after a fall.Instruments were brought from another hospital for the procedure.While assembling the instruments, dried blood was discovered.The surgeon was notified of the unsterile instruments and decided to proceed with the case while the instruments were flash sterilized.While waiting for the instruments to finish sterilizing, the patient coded.The surgeon was able to revive the patient.The kit used during this procedure was missing a locking mechanism for a the lag screws.

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 6 mdrs filed for the same event (reference 1825034-2015-05187-1 / 2016-00368 / 2016-00369 / 2016-00370 / 2016-00371 / 2016-00372).

Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Examination of returned device found no evidence of product non-conformance.Review of the device could not confirm the reported complaint.The root cause was most likely attributed to the improper cleaning and sterilization of the products at the previous hospital; however, a conclusive root cause could not be determined.

• Brand Name: SOLID LAG SCREW REAMER
• Type of Device: INSTRUMENT, MANUAL
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5332022
• MDR Text Key: 34579050
• Report Number: 0001825034-2015-05187
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 27915
• Device Lot Number: 99327
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR