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

Catalog Number 1000-00-101

Device Problems Mechanical Problem (1384); Noise, Audible (3273); Complete Loss of Power (4015)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

It was reported that during an unspecified surgical procedure, it was observed that while in use with a fully charged battery device the kincise impactor device made a quiet click noise while engaging the trigger and could not move forward.Multiple battery devices were tried but the clicking noise was still present.The user opened another impactor device and tried both batteries and both batteries worked.The user tried the original impactor again and got the same result.During in-house engineering evaluation, it was observed that the anvil would automatically extend when manually retracted due to trapped internal pressure from failing seals, allowing fluid ingress inside the unit and damaging internal components.The device was unable to move forward or reverse and had unintended motion.The device also failed pretests for impactor operation assessment, intermittent test assessment and final assessment.There were no delays in the surgical procedure as an identical spare device was available for use.There was patient involvement.There were no 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.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that reported condition of the device making unexpected noise and would not run were confirmed however difficult or unable to move forward was not confirmed.The assignable root cause was caused by normal wear due to general tool degradation since the impactor met its life expectancy due to its age.Udi: (b)(4).

• 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 ; 3035526892
• MDR Report Key: 18215922
• MDR Text Key: 329116032
• Report Number: 1045834-2023-01648
• 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: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• 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: 09/29/2023
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2022
• 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