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

Catalog Number 1010-01-101

Device Problems Dent in Material (2526); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

Udi : (b)(4) - the device manufacture date is currently unavailable.Device manufacture date: the device manufacture date is unavailable.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted 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 kincise broach-adapter device was dented and there was a sharp edge on the top.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.Udi : (b)(4).Device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 12/20/2017.Device history record review: a device history review was performed and no non-conformances were detected related to the reported condition.Device evaluation: the device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Quality engineering evaluated the device and the reported condition was confirmed.A visual and functional assessment was performed on the adapter device which found that the broach adapter was dented and had sharp edges (cosmetic damage).It was further observed that the device appeared to have been dropped, causing some denting to the top of the adapter (user error).The assignable root cause was due to user error.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 8455685
• MDR Text Key: 139989939
• Report Number: 1045834-2019-53254
• 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: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• 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: 03/12/2019
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1