MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE¿ AUTOMATED SURGICAL IMPACTOR; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER

Catalog Number 1000-00-101

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

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

Event Date 02/11/2024

Event Type  malfunction  

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 has been returned and is currently pending evaluation.Once the evaluation of the device has been completed, a supplemental medwatch report will be sent accordingly.Udi - (b)(4).

Event Description

It was reported that after an unspecified surgical procedure it was observed that the gun of the impactor device was dropped from a case cart and the back part of the shell broke off causing the inner part of the gun to be exposed.This event did not occur during surgery.There was no patient involvement.There were no reports of 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.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 was confirmed.The device was visually inspected, and it was found to fail visual inspection due to the rear housing being broken.The device was visually and functionally assessed and determined to operate but the rear housing was observed to be cracked with missing pieces, consistent with having been dropped.Also, the anvil is difficult to extent/retract consistent with lack of lubricant.The impactor operated as intended, except for the anvil being difficult to extend\retract and cracked housing.No further action is required at this time since the issues are consistent with user error (improper handling) and improper maintenance.

• Brand Name: KINCISE¿ AUTOMATED SURGICAL IMPACTOR
• Type of Device: IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
• 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: 18758948
• MDR Text Key: 336999037
• Report Number: 1045834-2024-00194
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• 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: 02/15/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2019
• 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