MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC KINCISE AUTOMATED 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 Limb Fracture (4518)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Additional narrative: udi: the serial number was unknown; therefore, the device manufacture date is unknown, and the udi is incomplete.Udi: serial number unknown; (b)(4) unknown(21)unknown.

Event Description

It was reported from (b)(6) that during a hip surgery, it was discovered that while broaching the stem with the impactor device, the surgeons performed a repositioning and realized that there was a three millimeter (3mm) of too much leg length, and so they decided to put the broach a little deeper into the patients femur.The reporter indicated that the surgeons accomplished the task by using the impactor without applying force.It was further reported that in one moment, the device cracked the femur.According to the reporter, there was a long crack approximately ten centimeters (10cm) long, as a result, a 2x cerclage and a cemented stem was put in.It was reported that the plan was to operate both sides of the leg; however, due to the long delay in surgery and the risk of the patient to later apply too much force on the other leg, it was decided to complete only one side.It was reported that there were no fragments generated and the surgery was completed successfully.There was forty-five-minute delay to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.There were reports of injuries, medical intervention and/or prolonged hospitalization.It was reported that the incision had to be extended, post-operation treatment had to be adapted, the crack in the leg had to be cemented, and the second side of the leg was not operated on and had to be postponed to a later time.It was further reported that the bone quality was not as good as expected from the x-rays.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: KINCISE AUTOMATED 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: 12615881
• MDR Text Key: 275912873
• Report Number: 1045834-2021-01650
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 00850915006006
• UDI-Public: 0850915006006
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1000-00-101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 65 YR