FDA Adverse Event Malfunction Summary report: N

KINCISE¿ AUTOMATED SURGICAL IMPACTOR

MDR report key: 14802036 · Received June 24, 2022

Report

Report Number: 1045834-2022-00758
Event Type: Malfunction
Date Received: June 24, 2022
Date of Event: June 10, 2022
Report Date: June 10, 2022
Manufacturer: THE ANSPACH EFFORT LLC
Product Code: GEY
UDI-DI: 00845384018520
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: THE COMPLETE FACILITY ADDRESS WAS NOT PROVIDED. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. UDI ¿ (B)(4).

Description of Event or Problem · 0

IT WAS REPORTED THAT WHILE USING THE IMPACTOR DEVICE TO BROACH THE FEMUR DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT DEVICE CONTINUED IMPACTING IN A CONTINUES FASHION WITHOUT THE TRIGGER BEING HELD DOWN. IT WAS REPORTED THAT THERE WAS A DELAY TO COMPLETE THE SURGERY, HOWEVER, THE EXACT DURATION OF THE SURGICAL DELAY WAS NOT REPORTED. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 REPORT WILL BE SUBMITTED ACCORDINGLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
635443	KINCISE¿ AUTOMATED SURGICAL IMPACTOR	MOTOR, SURGICAL INSTRUMENT, AC-POWERED	GEY	THE ANSPACH EFFORT LLC	1000-00-101		00845384018520

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown