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 01/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products and therapy dates: pinnacle cup device, liner device, summit stem device, broach device, (b)(6) 2020.The actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported that during an unspecified surgical procedure, it was discovered that while the kincise surgical impactor device was being used on the final stem, the femur cracked.According to the reporter, the device was used to put in the final acetabular cup and poly liner.Then, the femur was reamed and broached using the surgical impactor device.It was reported that there was no apparent fracture until implanting the final stem with the surgical impactor.The reporter indicated that when implanting, it seemed to be going in normal, but it sat a couple of millimeters lower than anticipated, and the fracture was observed at that point.It was reported that the device seemed to be functioning as expected during the duration of the procedure.It was further reported that the medical staff had no explanation for the cause of the fracture other than the surgical impactor.The reporter indicated that they did not know if there were any further precautions other than the intra-operative cabling for the patient.It was reported that the products being used at the time of the event were a pinnacle cup, liner and a summit stem, and none of the products were expected as the cause of the fracture.It was reported that there was five-minute delay to cable the femur afterwards.There was patient involvement reported.It was reported that there was no alleged malfunction against the device as it was reported to have been functioning as expected during the procedure.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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
• Manufacturer (Section G): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC 29625
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6103142063
• MDR Report Key: 9702070
• MDR Text Key: 179469998
• Report Number: 1045834-2020-00179
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention