MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD INVUITY®O EIGR TM SURGICAL ILLUMINATION SYSTEM; SURGICAL LAMP

Model Number N/A

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

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

Event Date 06/08/2015

Event Type  Injury  

Event Description

It is reported the light clip broke while the surgeon was repositioning the retractor.An additional fifteen (15) minutes were taken to retrieve the pieces that the surgeon could locate, however it was not determined if all pieces were recovered.No adverse effects as a result of the event have been reported.

Manufacturer Narrative

Review of device history records show that 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.Device product code is fst.

Manufacturer Narrative

Fields were updated based on the device being received for evaluation.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

The returned wave guide was reviewed.The clear portion has broken into several pieces.The device history record for lot 1402801 was reviewed.There were no non-conformances or temporary deviations associated with these wave guides.There are no indication of manufacturing issues associated with this lot.The surgical technique guide states "to ensure proper seating of the wave guide, place the wave guide onto the blade going straight down, ensuring the black cover sits inside the black channel." the most likely root cause is positioning/alignment during the surgical procedure.

• Brand Name: INVUITY®O EIGR TM SURGICAL ILLUMINATION SYSTEM
• Type of Device: SURGICAL LAMP
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 4896062
• MDR Text Key: 6535249
• Report Number: 3004485144-2015-00016
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK113697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: N/A
• Device Catalogue Number: 8735-0041
• Device Lot Number: 14102801
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other