T-FIX RCG STERILE PAC

MDR report key: 6639403 · Received June 14, 2017

Report

Report Number: 1219602-2017-00602
Event Type: Malfunction
Date Received: June 14, 2017
Date of Event: May 19, 2017
Report Date: September 6, 2017
Manufacturer: SMITH & NEPHEW, INC.
Product Code: HAB
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

DEVICE INVESTIGATION NARRATIVE - ONE 014771 T-FIX RCG STERILE PAC (2MM STERILE T FIX RCG DRILL AND SLEEVE) RETURNED. THE DRILL TAIL HAS BEEN SNAPPED OFF. PER A PHOTO UPON ORIGINAL RECEIPT, IT WAS RETURNED BUT WAS INADVERTENTLY LOST DURING INTERNAL TRANSIT. UPON FINAL DESTINATION, THAT TAIL PIECE WAS ABSENT FROM THE PACKAGE. THERE ARE SCRATCHES AND DINGS ON THE BLADE FLUTES. THE DRILL SHAFT AND SLEEVE ARE BENT AT THE DISTAL END. THERE ARE GOUGES OUT OF THE SLEEVE TIP. THERE ARE SEVERAL SPIRAL SCRATCH BANDS ALONG THE SLEEVE SHAFT; PROXIMAL AND DISTAL. THESE ARE ALL SIGNS LOSING AXIAL ALIGNMENT. PER THE IFU: ¿AS WITH ANY SURGICAL INSTRUMENT, CAREFUL ATTENTION SHOULD BE EXERCISED TO ENSURE THAT EXCESSIVE FORCE IS NOT PLACED ON THE INSTRUMENT. EXCESSIVE FORCE CAN RESULT IN INSTRUMENT FAILURE.¿ NO ROOT CAUSE ASSOCIATED WITH THE MANUFACTURE OF THIS DEVICE COULD BE SUPPORTED NOR PROVEN. NO FURTHER INVESTIGATION WARRANTED.

Description of Event or Problem · 1

WHEN DRILLING INTO HARD BONE WITH THE TFIX DRILL ATTACHED TO THE CHUCK THE TFIX DRILL CONNECTION (CHUCK END) SNAPPED OFF COMPLETELY WHEN DRILLING INTO THE GLENOID THROUGH THE DRILL SLEEVE (HARD BONE). A BACKUP DEVICE WAS READILY AVAILABLE. THERE WAS A DELAY OF LESS THEN 30 MINUTES. NO PATIENT INJURIES REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
420410	T-FIX RCG STERILE PAC	SAW, POWERED, AND ACCESSORIES	HAB	SMITH & NEPHEW, INC.		50606811

Patients

Seq	Age	Sex	Outcome	Treatment
1	20 YR