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

Catalog Number 1010-01-101

Device Problems Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The date of manufacture was unknown.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.  if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that during service and repair pre-testing, it was discovered that the adapter device had a sharp edge near the front, the locking latch felt loose and the broach device moved in multiple directions and it did not feel secure.The event was not related to surgery.There was no patient involvement.There were no injuries or medical intervention associated with this event.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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.The device manufacture date was reported as unknown in the initial report.The date has been updated to sep 26, 2017.The actual device was returned for evaluation.Quality engineering evaluated the device and determined that the broach adapter was dented and had sharp edges near the front therefore the device could not hold the broach securely.When the broach was locked, it moved in multiple directions and felt loose.The broach did move when latched into the adapter but no defect is found.The movement was determined to be due to normal from wear of the adapter over time and does not affect the functionality of the adapter and broach.It was noted that the adapter had exceeded its life expectancy.Therefore, the reported condition was confirmed.The adapter appeared to have been dropped causing some denting on top of the adapter which is user error.A review of the device history was performed, and no non-conformances were detected related to the reported condition.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: KINCISE BROACH-ADAPTER-STRAIGHT
• 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: 8452236
• MDR Text Key: 139869351
• Report Number: 1045834-2019-53205
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006037
• UDI-Public: 850915006037
• 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
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1010-01-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1