SAGITTAL SAW ATTACHMENT/LONG FOR TRAUMA RECON SYSTEM
Report
- Report Number
- 3009450871-2014-10364
- Event Type
- Malfunction
- Date Received
- August 28, 2014
- Report Date
- August 4, 2014
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HWE
- PMA / PMN Number
- PEXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
ADDITIONAL NARRATIVE: ADDITIONAL INVESTIGATION ON THE PRODUCT WAS COMPLETED: REVIEW OF PRODUCTION HISTORY REVEALED THAT ALL INVESTIGATED INSTRUMENTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS. NO ABNORMAL FINDINGS WERE IDENTIFIED. IT APPEARS THAT THE CLAMPING SCREW OF THE SAW ATTACHMENT WAS NOT TIGHTENED HARD ENOUGH. ANOTHER ROOT CAUSE MIGHT BE THE USAGE OF NON SYNTHES SAW BLADES OR USING THE ATTACHMENT WITH TRAUMA RECON SYSTEM MODULAR IN OTHER THAN SAW MODE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4)
ADDITIONAL NARRATIVE: MANUFACTURING EVALUATION: THE SAW ATTACHMENT 05.001.224 AND DEDICATED T-HANDLE 05.001.229 FOR TRS MODULAR HAND PIECES WERE INSPECTED ON (B)(4) 2015. ALL TESTING WAS PERFORMED ACCORDING TO PRE-REPAIR DIAGNOSTIC ASSESSMENT/INCOMING INSPECTION DOCUMENTATIONS. THE ATTACHMENT AND THE TOOL PASSED ALL TESTING. THE COMPLAINT CONDITION WAS TESTED WITH MALE AND FEMALE USERS, THE "SAW BLADE BECOMES LOOSE" DID ONLY OCCUR WHEN THE CLAMPING SCREW WAS NOT TIGHTENED HARD ENOUGH WITH DEDICATED T-HANDLE. AS A REFERENCE VALUE, A MINIMUM FIXATION TORQUE OF 5NM WAS EXPERIENCED, WHICH WAS POSSIBLE TO BE ACHIEVED BY FEMALE PROBANDS. THE ALLEGED "SAW BLADE HAS COME LOOSE DURING SURGERY - THE SAW BLADE HAS BEEN FIXED HARD SEVERAL TIMES" COMPLAINT THAT WAS REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. BACKGROUND INFORMATION: THE SAW ATTACHMENT 05.001.224 MUST ALWAYS BE USED IN SAW MODE (80% LESS POWER OUTPUT OF THE POWER MODULE). THE SAW BLADE MUST BE TIGHTENED HARD (TURNING THE SCREW-CLAMPING-MECHANISM TO THE END) AND DOUBLE-CHECKED BEFORE USAGE. ONLY ORIGINAL SYNTHES SAW BLADES ARE RECOMMENDED. DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE WERE NO NCRS WERE GENERATED DURING PRODUCTION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE COMPLAINT RECEIVED STATES THAT SAW BLADE HAS COME LOOSE DURING SURGERY. THE SAW BLADE HAS BEEN FIXED SEVERAL TIMES. NO PATIENTS HARM REPORTED. THIS IS REPORT NUMBER 1 OF 2 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 525497 | SAGITTAL SAW ATTACHMENT/LONG FOR TRAUMA RECON SYSTEM | INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH | HWE | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |