INNOVATOR X
Received Dec 21, 2020 · Event occurred Oct 30, 2020
Report 3008523132-2020-00002 · MDR key 11048020
Device
Product problems
- Loose or Intermittent Connection
Patient
Not reported
- Discomfort
- Discomfort
Narrative
Description of Event or Problem
THE PATIENT HAD SURGERY ON A TORN BICEPS IN (B)(6) 2020. AFTER A FEW WEEKS CASTING THE INNOVATOR X WAS FITTED ON THE ARM. LATER THAT DAY THE PATIENT WAS STARTLED BY SOMETHING AND STRETCHED HIS RIGHT ELBOW, CAUSING THE LOCK TO LOOSEN. PATIENT INDICATED THAT BRACE IS VERY UNCOMFORTABLE DURING USE AND HE IS NOT HAPPY WITH THE BRACE IN GENERAL.
Additional Manufacturer Narrative
IFU PROVIDES INSTRUCTIONS THAT AFTER THE RANGE OF MOTION ADJUSTMENT IN STEP 8 FOR "ENFORCED COMPLIANCE: LOOP AND SECURE THE ENCLOSED LOCK TIES THROUGH THE HOLES IN THE FLEXION AND EXTENSION BUTTONS TO LIMIT RANGE OF MOTION ADJUSTMENT." NO FIELD ACTION, CORRECTION, OR REMOVAL IS REQUIRED AS THIS IS CONSIDERED USE ERROR, WHERE THE ZIP TIES WEREN'T INSTALLED AND THIS IS THE FIRST REPORTED OCCURRENCE OF SHARP EDGES. THE IFU PROVIDES CLEAR INSTRUCTION THAT ZIP TIES WERE TO BE INSTALLED AFTER THE RANGE OF MOTION WAS APPROPRIATELY ADJUSTED. TREND ANALYSIS: (B)(4). SALES: 141,885. ROM INADEQUATE: 1. SHARP EDGE: 1. P1 (ROM): 1/141885 = 7.05E-06. P1 (SHARP EDGE): 1/141885 = 7.05E-06.
Description of Event or Problem
THE PATIENT HAD SURGERY ON A TORN BICEPS ON (B)(6) 2020. AFTER A FEW WEEKS CASTING THE BRACE WAS FITTED ON THE ARM. LATER THAT DAY THE PATIENT WAS STARTLED BY SOMETHING AND STRETCHED HIS RIGHT ELBOW, CAUSING THE LOCK TO LOOSEN DUE TO USE ERROR AS THE ZIP TIES WEREN'T INSTALLED TO PREVENT UNINTENDED INCREASE OF MOTION. THE PATIENT TORE HIS BICEPS AGAIN, AND IT IS NOT POSSIBLE TO UNDERGO A SECOND OPERATION. AS A RESULT, THE PATIENT HAS LIMITED STRENGTH IN HIS ARM. HE MAY REGAIN A CERTAIN DEGREE OF STRENGTH AND MOBILITY WITH ENOUGH PHYSICAL THERAPY. PATIENT INDICATED THAT BRACE IS VERY UNCOMFORTABLE DURING USE AND HE IS NOT HAPPY WITH THE BRACE IN GENERAL.