MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE BATTERY PACK; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 1002-00-102

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Electric Shock (2554)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device manufacture date: the device manufacture date is currently unavailable.Concomitant medical products and therapy dates: impactor device, (b)(6) 2019.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during testing prior to surgery, it was discovered that, as the technician was testing the impactor device and when they went to remove the kincise battery pack device, her fingertips were shocked.It was further reported that the technician¿s fingers were not close to the connectivity, and so they thought it must have been through the battery device.The event did not occur during surgery.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no patient involvement; however, there was user involvement reported.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The current status of the user is unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Corrected data: the date returned for evaluation was reported as nov 20, 2019 in the initial medwatch report.The date has been corrected to nov 25, 2019.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Correction: device availability: the device availability date was incorrect in the initial report.The date has been updated from 11/26/2019 to 11/20/2019.Device history record review: a device history review was performed and no non-conformances were detected related to the reported condition.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device.During repair, it was determined that the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, a visual and functional assessment was performed on the battery device which found that the battery pack operated as intended; however, it was determined that the battery terminals had some corrosion on them.It was determined that the probable cause of the corrosion was that the battery may have been exposed to sterilization with ¿sterrad¿ which is user error.It was further reported that all six (6) sides of the battery pack housing were visually inspected and no cracks or anomalies were observed.The assignable root cause was determined to be traced to maintenance, which is user error.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 12/21/2017.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: KINCISE BATTERY PACK
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC 29625
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6103142063
• MDR Report Key: 9383057
• MDR Text Key: 168213760
• Report Number: 1045834-2019-55003
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1002-00-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2017
• 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 Outcome(s): Required Intervention