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 08/19/2019

Event Type  Injury  

Manufacturer Narrative

The device serial/lot number was unknown; therefore, udi: (b)(4).Device manufacture date was 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

It was reported that during an unspecified surgical procedure, it was reported that the impactor device was used in conjunction with broach devices to broach the femoral canal.According to the reporter, the calcar, medial portion of the proximal femur at the level of the neck resection above the lesser trochanter, cracked while using the device.It was further reported that a circlage wire was placed around the proximal femur.It was reported that there was a ten minute delay in the surgical procedure.It was reported that a spare device was not available for use however, the surgery was completed successfully.There was patient involvement.There were no reports of prolonged hospitalization and the patient's post-operative status was 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.Udi: the device serial/lot number was unknown; therefore, udi: (b)(4).Correction: gtin number: the gtin number was incorrect in the initial report.The gtin has been updated from (b)(4) to (b)(4).The unique identifier( udi) has been updated accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.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.

• 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: 9037862
• MDR Text Key: 160615244
• Report Number: 1045834-2019-54418
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• 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: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR