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

Catalog Number 1010-01-102

Device Problem Material Fragmentation (1261)

Patient Problem Injury (2348)

Event Date 09/01/2020

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: actis broach device, attachment device, (b)(6) 2020.The surgeon¿s phone number was not provided.However, the contact¿s information was provided as: (b)(6).The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.Udi: (b)(4).

Event Description

It was reported that during an unspecified surgical procedure, it was discovered that the anterior broach adapter device broke the attachment off the actis broach device while the broach was being extracted.According to the reporter, the loss of the medial calcar was a result of the broach being stuck and having to take additional measures to extract it.The reporter further indicated that due to the broach attachment being broken off, it was not possible to attach an extraction device to the broach.This led to ¿chiseling¿ out the broach and losing bone stock that would have otherwise remained.It was reported that there was no loosening.It was further reported that all the pieces were retrieved from the patient.There was a thirty-minute delay to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.The reporter stated that there was no harm to the patient outside of the additional surgery time to remove ¿dig¿ the broach out, and possibly resulting in some medial calcar lost in the process.There were reports of medical intervention.However, there were no reports of prolonged hospitalization.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.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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the device operated as intended; however, it failed for locking latch assessment due to the broach post breaking off and getting stuck inside.It was further determined that the type of failure was consistent with user error.However, since the matting part (broach) was not returned, the definitive cause of the broach post breaking and getting stuck inside of the broach adaptor could not be determined.It was observed that the device had a component damage and would not lock/unlock.It was further determined that the device failed pretest for visual assessment, locking latch attachment assessment and locking latch removal assessment.Therefore, the reported condition was confirmed.The assignable root cause was determined to be traced to user, which is improper handling.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: KINCISE ANTERIOR 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
• MDR Report Key: 10588798
• MDR Text Key: 208609269
• Report Number: 1045834-2020-01535
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1010-01-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention