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

Catalog Number 1010-01-102

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

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Concomitant medical devices and therapy dates, broach adaptor device, broach devices, (b)(6) 2020.Reporter¿s complete mailing address was not provided.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during an unspecified surgical procedure, it was observed that the broach adapter device while broaching with varus pressure on healthy bone with at size 6 broach, bent at the post and became incarcerated in the anterior handle of the broach adapter.It was further reported that the user elected to move up to a size 8 broach.While broaching with the same varus pressure, it was observed that the post of the size 8 broach sheared off at the midpoint of the post.It was further reported that the broken broach was extracted from the canal using a vice grip slap hammer.It was reported that all the pieces were retrieved.It was reported that there were an eight minute delay due to prophylactic irrigation and the opening of another broach tray used to complete the procedure.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

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H4: the device manufacture date was documented as unknown in the initial report.It has been updated to (b)(6)2019.The actual device was returned for evaluation.Quality engineering performed a visual and functional assessment of the device which determined that the broach device could not be inserted into the adapter device due to a piece of a broach being broken off inside.It was determined that the cause of the broken off piece of broach device was due to side loading of the adapter during use which is user error.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to user error.A device history review 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.If additional information should become available, a suplemental medwatch will be submitted accordingly.

• Brand Name: KINCISE BROACH-ADAPTER-ANTERIOR
• 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: 9633839
• MDR Text Key: 176684701
• Report Number: 1045834-2020-00149
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1010-01-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR