MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE BROACH-ADAPTER-ANTERIOR; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER

Catalog Number 1010-01-102

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Udi ¿ (b)(4).Device manufacture date: the device manufacture date is unavailable.Concomitant med products: adapter device.Reporter's phone number was not provided.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 2 of 2 for the same event.It was reported that during an unspecified surgical procedure it was observed that the adapter devices were not staying locked during use.It was not reported if there was a delay in the procedure due to the event.It was not reported if there was a spare device available for use.There was patient involvement reported.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.Additional information: the date of manufacture (dom) was documented as unknown in the initial medwatch report.The dom has been updated to june 17, 2017.Therefore, udi:(b)(4).Device evaluation: the actual device was returned for evaluation and testing.Quality engineering evaluated the device and the reported condition that the adapter was not staying locked during use was confirmed.An assessment was performed on the device which found that the adapter was non-functional.The adapter was in pre-design change form.The design change removed material from two different surfaces to improve the latching mechanism by allowing the leaver to travel further when closing to address this issue, no further investigation is needed at this time.It was determined that the assignable root cause was due to be improper construction and design.A review of the device history was performed and no non-conformance's were detected related to the reported condition.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: KINCISE BROACH-ADAPTER-ANTERIOR
• Type of Device: IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8717984
• MDR Text Key: 148966985
• Report Number: 1045834-2019-53863
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006044
• UDI-Public: 850915006044
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• 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: 06/17/2019
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1