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

Catalog Number 1010-01-102

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly.  reporter¿s complete mailing address was not provided.Concomitant med products and therapy dates: broach device; (b)(6) 2020.Udi:(b)(4).

Event Description

It was reported that while extracting the size 7 actis broach from the femoral canal with the adapter device, the top of the broach device connecter sheered off and broke.It was reported that the broach device was removed by hand, and the piece that was broken was found to be stuck inside of the adaptor device.There were no delays in the surgical procedure.It was not reported if a spare device was available for use.There was 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.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 the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the the broach post had broken off and was stuck inside.It was further determined that the device had component damage and failed pre-test for visual assessment, locking latch assessment, and locking latch removal assessment.Therefore, the reported condition was confirmed.It was noted that the matting part (broach) was not returned, therefore the true cause of the broach post broken and stuck inside of the broach adaptor could not be determined.The assignable root cause of the component damage and and the device not locking/unlocking was determined to be due to improper handling which is user error.

• 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: 10824051
• MDR Text Key: 215987543
• Report Number: 1045834-2020-01885
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• 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: 11/06/2020
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR