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

Catalog Number 1000-00-101

Device Problems Electrical /Electronic Property Problem (1198); Environmental Particulates (2930); Appropriate Term/Code Not Available (3191); Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Name of user facility was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).

Event Description

It was reported that during an unspecified surgical procedure it was observed that the impactor device fired twice then quit working.It was reported that the handpiece started moving and an electrical smell was noticed.It was reported that there was no smoke.It was reported that the device taken out of the room immediately.It was not reported if there was a spare device available for use.There was patient involvement reported.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the impactor device and the reported condition that the device worked once in a case then quit was confirmed.The device was visually inspected as received and the device passed visual inspection.It was noted that the impactor would not function at all; failed the functional assessment.There was no notable wire damage nor leaks at initial deconstruction.The rear can was removed and there was visual indication of printed circuit board assembly (pcba) failure.The impactor was taken for evaluation, and it was determined that the damage observed was primarily in the mosfet area of the pcba.This is generally from a spike in current or voltage.The best-known instance for a spike in the current in regard to the impactor is motor binding.The motor was removed from the impactor with some force.There was metallic filings and the drive body bearing shelf shows wear.The motor shim/bearing assembly had ground into the shelf and became bound.If the motor was bound and was continually tried to impact, the mosfets of the pcba can short out and cause failure.It was noted that smoke/smell was not noted during evaluation.It was determined that the cause for the found defect is a confirmed design error; the motor shim had ground into the drive body shelf and became bound.Electronics unable to overcome resistant load.This trend has been captured in a capa.A review of the device history was performed and no non-conformances were detected related to the reported condition.

• Brand Name: KINCISE AUTOMATED SURGICAL IMPACTOR
• 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 ; 6107428552
• MDR Report Key: 12520350
• MDR Text Key: 273202296
• Report Number: 1045834-2021-01605
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1000-00-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2020
• 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