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

Model Number 1000-00-101

Device Problems Device Slipped (1584); Device Damaged by Another Device (2915)

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 the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the reported condition was confirmed.The assignable root cause was traced to user error.Udi: (b)(4).

Event Description

It was reported that the kincise impactor device was coming apart.During in-house engineering evaluation, it was determined that the device fell apart - unattached and had component damage.The device also failed pretests for visual assessment and final assessment.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• 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: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 16642824
• MDR Text Key: 312301294
• Report Number: 1045834-2023-00463
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00845384018520
• UDI-Public: 00845384018520
• 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
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1000-00-101
• Device Catalogue Number: 1000-00-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1