MAUDE Adverse Event Report: INTEGRA YORK, PA INC. LITHIUM ION BATTERIES - QTY 2; LIGHTING

Catalog Number 90522

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports that the battery was getting hot inside holster on surgeons hip.On (b)(6) 2016 customer reports that doctor was performing a spinal fusion when he felt the battery was hot, after one hour of use.Battery was removed from holster.The heat burned a hole in the battery.No harm to the doctor.#1 of 2 related complaints.

Manufacturer Narrative

On 6/7/2016 integra investigation completed.Manufacture date unknown method: failure analysis, device history evaluation, results: failure analysis - battery only received.Inserted battery into holster, connected to led headlight for 2 hours on highest setting.Run time temp was 81.9f, which is not an abnormal temperature for a battery in use.Battery tests within specification.Complaint report is unconfirmed.Device history evaluation - nonconforming product report / nonconforming material report history: none.Variance authorization / deviation history: none.Engineering change order / manufacturing change order history: none.Corrective action preventive action history: none.Health hazard evaluation history: none.Conclusion: the report of battery getting hot inside holster could not be confirmed.After the evaluation of the returned sample, it was found that the battery could power a headlight and not over-heat in holster.The complaint report is unconfirmed; testing within specifications.

• Brand Name: LITHIUM ION BATTERIES - QTY 2
• Type of Device: LIGHTING
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5669471
• MDR Text Key: 45587210
• Report Number: 2523190-2016-00070
• Device Sequence Number: 1
• Product Code: FSR
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 90522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 05/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 YR