MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE SURGICAL IMPACTOR; IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER

Catalog Number 1000-00-101

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that during an unspecified surgical procedure it was observed that the impactor device misfired when the trigger of the device was pulled.It was not reported if there were any delays 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 any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

H10: 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.D10: additional narrative: the actual device was returned for evaluation.Quality engineering evaluated the impactor device and the reported condition that the device misfires when the trigger is pulled was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the battery terminal was bent.It was determined that this condition was due to improperly inserting the battery pack.The assignable root cause of this condition was determined to be traced to user, 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 report will be submitted accordingly.

• Brand Name: KINCISE SURGICAL IMPACTOR
• 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: 9474230
• MDR Text Key: 191805912
• Report Number: 1045834-2019-55142
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006006
• UDI-Public: 850915006006
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1000-00-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1