MAUDE Adverse Event Report: EBI, LLC. OSTEOGEN BONE GROWTH STIMULATOR; STIMULATOR, INVASIVE BONE GROWTH

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported during a hip core decompression the bone stimulator was placed into the patient's body.The surgeon was attempting to place the lead where he wanted it when the wire broke off rendering the implant useless.The surgery was completed without using a bone growth stimulator.

Manufacturer Narrative

The product was returned for evaluation.The product identity was confirmed through the visual inspection.Based on the evaluation, the product was returned in a plastic bag with the unit cathode broken.The device was tested and found to operate as intended despite the break.The most-likely root cause for the broken titanium wire was determined to be caused by the physician who caused fatigue on the wire until it broke.The cause of the event was determined to be not related to the manufacturing process.

Manufacturer Narrative

The titanium wire was sent for further analysis by zimmer biomet warsaw research lab.The analysis confirms the most-likely cause of the titanium wire fracture was overload as the three wires showed ductile overload dimples.The most-likely cause for the overload was determined to be abrupt use by the physician during surgery.

• Brand Name: OSTEOGEN BONE GROWTH STIMULATOR
• Type of Device: STIMULATOR, INVASIVE BONE GROWTH
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: michelle cole ; 399 jefferson road; parsippany, NJ 07054
• MDR Report Key: 5967178
• MDR Text Key: 55273692
• Report Number: 0002242816-2016-00026
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP850035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2016
• Device Model Number: N/A
• Device Catalogue Number: 10-1320
• Device Lot Number: 565-15
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2016
• Initial Date FDA Received: 09/21/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/24/2016; 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR