OSCILLATING SAW BLADE STRYKER® SYSTEM 7, 6, 5, 4, 2000 AND EHD
Report
- Report Number
- 0002950261-2016-00001
- Event Type
- Malfunction
- Date Received
- January 7, 2016
- Date of Event
- December 9, 2015
- Report Date
- February 19, 2016
- Manufacturer
- SYNVASIVE
- Product Code
- GFA
- Removal / Correction Number
- N/A
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
THE DEVICE IS MANUFACTURED IN THE (B)(4). THE INFORMATION FOR THIS RESPONSE WAS PROVIDED BY THE QUALITY DEPARTMENT AT THE (B)(4). 1309012YG1 IS THE CATALOGUE NUMBER FOR PURCHASING THE STABLE ZIM GTS OSC ST 90 X 460X 1.27MM SAW BLADE. THE EL DORADO HILLS DETAIL COMPONENT PRODUCTION PART NUMBER FOR THIS BLADE IS 11-4763-01. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED FOR PART # 11-4763-01, WO # (B)(4). MANUFACTURING OF THE LOT BEGAN ON 2/11/2015 AND THE LOT WAS RELEASED INTO INVENTORY ON 4/2/2015. THERE WERE NO NON-CONFORMANCES DURING MANUFACTURE. ALL TESTING AND INSPECTION REQUIREMENTS WERE MET. THE SAW BLADE WAS RETURNED TO ZIMMER BIOMET SURGICAL ON 1/7/2016. VISUAL INSPECTION WAS PERFORMED AND PHOTOGRAPHS WERE TAKEN USING A DIGITAL MICROSCOPE. THE INCOMING INSPECTION FOUND ONE SIDE SAW TOOTH MISSING AND SIGNIFICANT DAMAGE TO THE OPPOSITE SIDE TOOTH. ADDITIONALLY, THE TIPS OF THE INTERIOR TEETH DISPLAYED SOME DAMAGE. FURTHERMORE, BOTH BODY EDGES OF THE SAW DISPLAYED SIGNIFICANT IMPACT DAMAGE. THE DENTS AND ROLLED METAL ON THE EDGES OF THE SAW BLADE AND THE DAMAGE TO THE END SAW TEETH ARE INDICATIVE OF THE OSCILLATING SAW BLADE STRIKING A HARD SURFACE LIKE THE SAW CUTTING GUIDE BLOCK OR A STAINLESS STEEL TRAY OR TABLE. NO FUNCTIONAL TEST WAS WARRANTED. THE CUSTOMERS REPORTED EVENT WAS THAT THE SAW BLADE TOOTH BROKE AWAY AFTER SEVERAL CUTS DURING USE. THE CUSTOMERS REPORTED EVENT OF THE SAW TOOTH BREAKING AWAY IS CONFIRMED. THE DIGITAL MICROSCOPE INSPECTION DEPICTS THE DAMAGE TO THE SAW BLADE IN A LATERAL MANNER. ALMOST ALL OF THE DAMAGE IS ON THE SIDE EDGES OF THE SAW BLADE AND THE MISSING SAW TOOTH IS ON THE EDGE AS WELL. THE CUSTOMER REPORTED THAT THE TOOTH BROKE AWAY DURING USE AFTER SEVERAL PREVIOUS CUTS. THE LATERAL DAMAGE TO THE EDGES OF THIS OSCILLATING SAW BLADE WAS MOST LIKELY CAUSED BY THE MOVING SAW BLADE STRIKING THE STEEL CUTTING GUIDE BLOCK. MOVING THE SAW BLADE BACK AND FORTH IN THE CUTTING GUIDE WITH THE SAW ACTIVATED WOULD CAUSE REPETITIVE IMPACT TO THE SAW EDGES. IN ADDITION, IF THE EDGE TOOTH IMPACTED THE CUTTING BLOCK DURING USE THE IMPACT COULD CAUSE THE TOOTH TO BREAK OFF. CONSEQUENTLY, THE MOST PROBABLY ROOT CAUSE FOR THIS EVENT IS USER DAMAGE BY ACCIDENTALLY HITTING THE MOVING SAW BLADE AGAINST A HARD SURFACE OF THE CUTTING GUIDE BLOCK. THIS REPORTED EVENT IS NOT CONSIDERED AN OUT OF THE BOX EVENT. CUSTOMER REPORTED DAMAGE OCCURRED DURING USE. THERE ARE NO RECOMMENDED ACTIONS AT THIS TIME. THE RISK ASSESSED WITHIN THE CONTEXT OF THIS COMPLAINT INDICATES THAT THE ISSUE IS WITHIN ACCEPTABLE LIMITS IN TERMS OF SEVERITY AND OCCURRENCE.
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.
IT WAS REPORTED THAT DURING A KNEE SURGERY, ONE TOOTH OF THE BLADE BROKE AWAY OF THE BLADE (AFTER SEVERAL CUTS, NOT A THE FIRST ONE). THERE WAS NO EXTENSION IN SURGERY TIME, NO HARM, INJURY OR ADVERSE EVENT TO PATIENT/OPERATOR, NOR WAS THE LIFE/HEALTH OF PATIENT AT RISK. THE SURGERY WAS COMPLETED WITH AN ALTERNATE DEVICE. NO MEDICAL INTERVENTION/ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10133 | OSCILLATING SAW BLADE STRYKER® SYSTEM 7, 6, 5, 4, 2000 AND EHD | ZIMMER OSC GTS ST HUB 90MM X 13MM X 1.27MM | GFA | SYNVASIVE | N/A | 52080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |