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

Model Number 1000-00-101

Device Problems Physical Resistance/Sticking (4012); Intermittent Loss of Power (4016)

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

Event Type  malfunction  

Event Description

It was reported that the impactor device was misfiring after several attempts with new batteries.During inhouse engineering evaluation it was determined that the device had a sticky trigger.This event did not occur during surgery.There was no patient involvement.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.Additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the impactor device, and the reported condition was confirmed.It was determined that the device failed visual inspection.During the assessment of the device, it was observed that the impactor operated.However, the latch assembly was dissembled, and the assembly screw was missing preventing the battery pack from being inserted, seated, and secured.Also, the trigger screw was loose, the battery lock was missing a screw and from one side there were visible signs that the screw was originally there including scratch marks and loctite residue.It was further observed that the housing was loose, and the trigger was not secure and able to move.Upon removing the rear housing it was found that the trigger screw was loose.The screw was removed to ensure that loctite had been applied during manufacturing.There was loctite residue on the screw as well as on the inside of the threads.It was determined that these issues were a result of general tool degradation due to unit being beyond life expectancy.The assignable root cause of these conditions was determined to be traced to component failure due to wear.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 33410 ; 3035526892
• MDR Report Key: 15723202
• MDR Text Key: 303320936
• Report Number: 1045834-2022-01476
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• 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: 09/02/2022
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2019
• 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