NORCO SHOULDER PULLEY
Received Mar 23, 2012 · Event occurred May 30, 2011
Report 2939821-2011-00016 · MDR key 2504738
Device
Generic name
Shoulder Pulley
Manufacturer
North Coast Medical, Inc.Model number
NC52069Catalog number
NC52069
Lot number
NA
Product problems
- Break
Patient
86 YR
- Rupture
- Injury
Narrative
Description of Event or Problem
ON (B)(6) 2011, CUSTOMER WAS REHABILITATING HIS LEFT SHOULDER, WHICH HAD RECENTLY UNDERGONE SURGERY, USING A NORCO SHOULDER PULLEY GIVEN TO HIM BY HIS TREATING PHYSICIAN. THE PULLEY'S WHEEL SNAPPED, CAUSING THE CUSTOMER TO SUSTAIN INJURY. ON (B)(6) 2011, THE CUSTOMER PRESENTED TO AN ORTHOPEDIC PRACTICE CENTER. PHYSICIAN'S ASSISTANT NOTED THAT THE CUSTOMER WAS WORKING OUT WITH HIS PULLEY TO MAINTAIN RANGE OF MOTION AFTER UNDERGOING A LEFT SHOULDER ARTHROPLASTY, WHEN THE PULLEY BROKE, CAUSING A FORCED EXTENSION INJURY TO THE RIGHT SHOULDER. X-RAYS OF THE RIGHT SHOULDER REVEALED A MASSIVE, UNREPAIRABLE ROTATOR CUFF TEAR AND SPONTANEOUS RUPTURE OF THE BICEPS TENDON. A GLENOHUMERAL JOINT INJECTION WAS ADMINISTERED FOR PAIN. ON (B)(6) 2011, THE CUSTOMER PRESENTED TO THE SAME ORTHOPEDIC PRACTICE CENTER. THE SAME PHYSICIAN'S ASSISTANT NOTED THAT THE CUSTOMER DECLINED SURGERY ON THE RIGHT SHOULDER, SO A GLENOHUMERAL JOINT INJECTION WAS ADMINISTERED. ON (B)(6) 2011, THE CUSTOMER PRESENTED TO THE SAME ORTHOPEDIC PRACTICE CENTER. PHYSICIAN'S ASSISTANT NOTED THAT THE CUSTOMER UNDERWENT A REPEAT INJECTION OF THE RIGHT SHOULDER, AND THAT HE WAS MARKEDLY DEBILITATED FROM HIS INJURY REGARDING THE PULLEY. THE CUSTOMER'S TREATING PHYSICIAN HAS PROVIDED A CAUSATION LETTER DOCUMENTING THAT HE HAS A PROBABLE CUFF TEAR WHICH PRESENTLY LEAVES HIS ARM FUNCTIONALLY WORTHLESS.