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

Catalog Number 1010-01-102

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device date of manufacture is unknown; therefore, udi: (b)(4).Device manufacture date is 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

This is report 1 of 4 for the same event.It was reported that during an unspecified surgical procedure, it was observed that the (4) adaptor devices were flipping open during impaction.It was not reported if there were any delays in the surgical procedure or whether a spare device was available for use.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The exact date of this event is unknown.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.The device manufacture date was documented as unknown in the initial report.It has been updated to april 20, 2017.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.During review of the device manufacturing records for this device indicates that no non-conformances were identified.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: KINCISE BROACH-ADAPTER-ANTERIOR
• 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: 8528909
• MDR Text Key: 142406574
• Report Number: 1045834-2019-53445
• Device Sequence Number: 1
• Product Code: GEY
• 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: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• 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?: No
• Date Manufacturer Received: 06/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADAPTOR DEVICES; ADAPTOR DEVICES