MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE POSTERIOR BROACH ADAPTER; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 1010-01-101

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

Patient Problem Injury (2348)

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: impactor device, broach device, battery device; (b)(6) 2020.The surgeon¿s phone number was not provided.However, the reporter¿s name, phone number and email address were provided as (b)(6).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-conformances identified that was related to the reported complaint condition.Udi: (b)(4).

Event Description

This is report 1 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.

• Brand Name: KINCISE POSTERIOR BROACH ADAPTER
• 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: 10876487
• MDR Text Key: 217438349
• Report Number: 1045834-2020-01945
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• 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: 1010-01-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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