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

Catalog Number 1000-00-101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); Unspecified Musculoskeletal problem (4535)

Event Date 11/03/2020

Event Type  Injury  

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.Concomitant med products and therapy dates: broach adapter device, broach device, battery device; (b)(6) 2020.(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This is report 2 of 2 of the same event: it was reported that during an unspecified surgical procedure, it was discovered that the trigger of the impactor device was accidentally engaged, injuring the surgical technologist¿s neck.It was further reported that the impaction tool trigger was accidentally pressed by the surgeon¿s nurse while the broach device and attachment (broach adapter) device where unlocked, resulting in the surgical technologist being hit directly in the neck by the discharged broach and attachment (broach adapter).The devices were also being used with the battery device.It was further reported that the surgical technologist was sent to the emergency room by the hospital for evaluation and was given the next day off.It was reported that the surgical technologist injuries were pain and swelling.It was reported that there was a ten-minute delay to the surgical procedure.It was not reported if spare devices were available for use.There was patient involvement reported.It was reported that the patient was not harmed.There were reports of medical intervention.However, there were no reports of prolonged hospitalization.There was no allegation of malfunction against the devices.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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: manufacturing record evaluation (mre) review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a manufacturing record evaluation (mre) was performed for the finished device serial number, which indicated that there were no non-conformance's identified that was related to the reported complaint condition.Device history record (dhr) review: a review of the device history record was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.

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.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed.The customer did not have any alleged malfunction against the device; therefore, the complaint could not be confirmed, and an assignable root cause was not determined.However, during evaluation, the device was visually inspected, and it was found that the device failed visual inspection due to the battery terminals being broken.During the assessment, it was observed that the device not to operate due to the battery terminals being broken, which was consistent with not properly aligning the battery pack ¿ user error.Additionally, pieces were missing.It was further determined that the device failed pretest for visual assessment, and impactor operation assessment.The assignable root cause was determined to be traced to user, which is improper handling / user error.

• 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 ; 6103142063
• MDR Report Key: 10876532
• MDR Text Key: 217438041
• Report Number: 1045834-2020-01947
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1000-00-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male