FDA Adverse Event Malfunction Summary report: N

VERSAFITCUP FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56

MDR report key: 6979454 · Received October 26, 2017

Report

Report Number: 3005180920-2017-00617
Event Type: Malfunction
Date Received: October 26, 2017
Date of Event: September 27, 2017
Report Date: October 26, 2017
Manufacturer: HPF S.P.A.
Product Code: LXH
Product Problem: Yes
Report Source: Distributor report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ON 25 OCTOBER 2017 THE MANUFACTURER OF THE INSTRUMENT INVOLVED IN THE COMPLAINT (HPF) PROVIDED A DOCUMENT REVIEW REPORTING AS FOLLOW: BATCH RELEASED ON DATE: 05/05/2017. N. OF PIECES RELEASED: (B)(4). COMMENTS: ALL THE STEPS, ACCORDING TO OUR ROUTING SHEET AND RELATIVE DRAWINGS, HAVE BEEN PERFORMED CORRECTLY AS WELL AS THE DIMENSIONAL AND FUNCTIONAL CONTROLS. FIRST COMPLAINT RECEIVED ON THIS LOT BY HPF. CONCLUSIONS: THERE AREN'T NON CONFORMITY ELEMENTS IN THE DOCUMENT REVIEW. INSPECTION: HPF HAVE NOT RECEIVED THE DEVICE. THE INSPECTION WAS NOT POSSIBLE. CONCLUSION: NOT HAVING THE POSSIBILITY TO ANALYZE THE DEVICE, WE SUPPOSE THAT THE RUPTURE COULD HAVE BEEN CAUSED BY A DRILL FLEXION DURING THE USE WHICH LED TO THE DRILL BREAKAGE. NO FURTHER INVESTIGATION ARE POSSIBLE FOR THE SUPPLIER BECAUSE THE DEVICE IS NOT AVAILABLE AND WE DON'T HAVE PICTURE OF THE EVENT.

Description of Event or Problem · 1

WHILE DRILLING FOR A SCREW, THE DRILL BIT BROKE. THE BIT FELL INTO THE PATIENT. THE BIT WAS RECOVERED. THE SURGEON USED A SECONDARY DRILL BIT TO COMPLETE THE SURGERY. THERE WAS A 20 MINUTE DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
758769	VERSAFITCUP FLEXIBLE BAYONET DRILL Ø 3.2 MM SHAFT L 56	SURGICAL INSTRUMENT FOR HIP	LXH	HPF S.P.A.		17H6305

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other