FDA Adverse Event Malfunction Summary report: N

ARTHROPIERCE 45 DEGREE LEFT

MDR report key: 5224329 · Received November 15, 2015

Report

Report Number: 1219602-2015-01161
Event Type: Malfunction
Date Received: November 15, 2015
Date of Event: April 3, 2014
Report Date: April 3, 2014
Manufacturer: SMITH & NEPHEW, INC.
Product Code: HRX
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(6). ONE 45 DEGREE LEFT ARTHROPIERCE WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE DEVICE CONFIRMED THE REPORTED COMPLAINT OF THE TIP BREAKING OFF. THE TIP WAS NOT RETURNED FOR EVALUATION. EXAMINATION OF THE REMAINING PORTION OF THE DEVICE CONFIRMED THE SHAFT IS BENT DRAMATICALLY TO THE RIGHT WHERE IT INTERFACES WITH THE HANDLE. THIS CONDITION IS CUSTOMER INDUCED DAMAGE DUE TO EXCESSIVE TORQUE APPLIED DURING USE. PER THE IFU 1060355 REV H UNDER ¿PRECAUTIONS¿ ¿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.¿ ALSO THE IFU INSTRUCTS ¿DO NOT USE THESE INSTRUMENTS AS LEVERS FOR MANIPULATING HARD TISSUE OR BONE. EXCESSIVE FORCE SHOULD NOT BE APPLIED TO THE INSTRUMENT WHEN MANIPULATING SOFT TISSUE, BONE, OR HARD OBJECTS. MISUSE OF THESE INSTRUMENTS MAY RESULT IN BENT DISTAL TIPS OR JAWS; AND DULL OR UNEVEN CUTTING EDGES.¿ NO ROOT CAUSE RELATED TO THE MANUFACTURE OF THE DEVICE CAN BE ESTABLISHED.

Description of Event or Problem · 1

WHEN THE SURGEON INSERTED THE ARTHROPIERCE INTO THE PATIENT'S CUFF, THE ARTHROPIERCE SNAPPED. THE BROKEN PRICE WAS RETRIEVED FROM PATIENT. NO PATIENT INJURY OR COMPLICATIONS RESULTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
754608	ARTHROPIERCE 45 DEGREE LEFT	ARTHROSCOPE	HRX	SMITH & NEPHEW, INC.		50405443

Patients

Seq	Age	Sex	Outcome	Treatment
1