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

Catalog Number 1013-00-901

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial reporter's facility address was not available.The date of manufacture was not available.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 an unspecified surgical procedure, it was observed that while impacting the femoral head onto the stem, the replacement head on the tip of the impactor device broke.It was reported that there was a thirty second delay in the surgical procedure and all pieces were retrieved.It was not reported whether a spare device was available for use.There was 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.Corrected data: d4: udi: (b)(4).H4: the date of manufacture was reported as unknown in the initial medwatch report and has been updated to aug 03, 2019.If additional information should become available, a supplemental medwatch report will be sent accordingly.

• Brand Name: KINCISE REPL CAP 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: 9711539
• MDR Text Key: 179621069
• Report Number: 1045834-2020-00273
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006143
• UDI-Public: 850915006143
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013-00-901
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1