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

Catalog Number 1013-00-101

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The date of manufacture was unknown.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 initial inspection, it was observed that the adapter device did not have a tip on it.This event did not occur during surgery.There was no 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.Udi: (b)(4).The date of manufacture was document as unknown in the initial medwatch report.This information has been updated to may 4, 2017.The actual device was returned for evaluation.Quality engineering evaluated the device and determined that the reported condition was not confirmed.A photograph was provided by kincise which indicated that the cap was assembled on the device prior to shipping.Therefore, the assignable root cause could not be determined.A review of the device history record 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 HEAD-ADAPTER-FEMORAL
• 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: 8515078
• MDR Text Key: 142039199
• Report Number: 1045834-2019-53426
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006105
• UDI-Public: 850915006105
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013-00-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1