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

Catalog Number 1000-00-101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/20/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Concomitant device and therapy dates: adapter device, stem device; (b)(6) 2020.Reporter's complete facility address and phone number were 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 additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

This is event 2 of 2 of the same event: it was reported that during an unspecified surgical procedure, the user was using the impactor device and an unknown adapter device for broaching and impacting the implant (stem).It was reported that the broaching went well.According to the reporter, upon insertion of the stem device, the femur was fractured.It was reported that the implant was removed and cables were placed on the femur.A new stem was opened and implanted using a manual insertion instrument.There was a fifteen minute delay to the surgical procedure.It was unknown if a spare device was available for use.There was patient involvement.It was reported that the patient was sent home on a modified protocol.There were no reports of prolonged hospitalization.There was no allegation of malfunction against the devices.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: h6: device history review: the actual device was not returned for evaluation; therefore, the reported condition was not confirmed.However, a device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.

• Brand Name: KINCISE SURGICAL IMPACTOR
• 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: 9825792
• MDR Text Key: 183287845
• Report Number: 1045834-2020-00404
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006006
• UDI-Public: 850915006006
• Combination Product (y/n): N
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1000-00-101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR