DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
Report
- Report Number
- 2520274-2017-11760
- Event Type
- Malfunction
- Date Received
- June 2, 2017
- Date of Event
- May 5, 2017
- Report Date
- May 5, 2017
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HTO
- PMA / PMN Number
- K042899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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.
REPORTED CONCOMITANT DEVICE: RIA REAMER HEAD Ø16.5 (PART# 352.259S, LOT# 9842342, QUANTITY 1) IS NOT CONCOMITANT. 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.
A PRODUCT INVESTIGATION WAS PERFORMED. THE DISTAL TIP OF ONE RIA DRIVE SHAFT (314.743, 9895470), AND THE PROXIMAL PRONGS OF TWO RIA REAMER HEADS (352.258, H091628 AND 352.263 LOT # 5847628) BROKE INTRAOPERATIVELY ON (B)(6) 2017. NO PROLONGATION OF SURGERY WAS REPORTED AND NO INFORMATION ABOUT PATIENT OUTCOME. ADDITIONALLY IT WAS DISCOVERED THAT ONE REAMER HEAD (352.259, 9842342) WAS NOT ABLE TO BE REMOVED FROM THE RETAINER TIP OF A RIA TUBE ASSEMBLY. TWO CONCOMITANT DISTAL RETAINER COMPONENTS (314.744.7) OF TWO TUBE ASSEMBLIES (314.745 AND/OR 314.746) WERE ALSO RETURNED, BUT WERE NOT FOUND TO HAVE CONTRIBUTED TO THE COMPLAINT CONDITIONS. THE RETURNED PARTS ARE INCLUDED IN THE REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM USED FOR INTRAMEDULLARY REAMING AND BONE HARVESTING. THE RIA DRIVE SHAFT (314.743, 9895470) WAS RECEIVED WITH ITS DISTAL TIP WHICH IS INTENDED TO COUPLE WITH REAMER HEADS, BROKEN OFF. ONE OF THE REAMER HEADS (352.258, H091628) WAS RETURNED WITH TWO OF ITS PROXIMAL PRONGS BROKEN OFF; ANOTHER REAMER HEAD (352.263, 5847628) WAS RETURNED WITH ALL FOUR OF ITS PROXIMAL PRONGS BROKEN OFF. A THIRD REAMER HEAD (352.259, 9842342) WAS RETURNED STILL ATTACHED TO A RETAINER COMPONENT OF A TUBE ASSEMBLY. UPON INSPECTION, THE REPORTED COMPLAINT CONDITIONS WERE CONFIRMED, WHICH MADE THEIR REPLICATION INAPPLICABLE. AS PART OF THIS INVESTIGATION A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED. THE RELEVANT DRAWINGS OF THE RETURNED PARTS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. NO MRRS, NCRS, OR ACTIONS RELATED TO THE COMPLAINT CONDITION WERE GENERATED DURING PRODUCTION OF THE RETURNED PART(S). REVIEW OF DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT(S) WHICH WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. IT IS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR WHY THE APPROXIMATELY 21.5MM DISTAL TIP (314_741) MEANT TO ENGAGE WITH REAMER HEADS, BROKE OFF. IT IS POSSIBLE THAT THE DAMAGE OCCURRED WHILE ATTEMPTING TO REAM EXCESSIVELY DENSE BONE, WHICH COULD HAVE EXPOSED THE DISTAL TIP OF THE DRIVE SHAFT TO EXCESSIVE TORQUE. REAMING OF EXCESSIVELY DENSE BONE COULD HAVE ALSO CONTRIBUTED TO THE RETURNED REAMER HEAD HAVING BROKEN PROXIMAL PRONGS. UPON RECEIPT OF THE RETURNED REAMER HEAD WHICH WAS RECEIVED STILL ATTACHED TO A RETAINER COMPONENT, THE ATTACHED REAMER HEAD WAS ABLE TO BE REMOVED, USING THE GUIDANCE FOUND IN THE RELEVANT RIA TECHNIQUE GUIDE. THE ROOT CAUSE FOR THE DRIVE SHAFT FAILURES IS ATTRIBUTED TO HUMAN ERROR, SPECIFICALLY MISALIGNMENT DURING ASSEMBLY AND TORQUEING OVER SPECIFICATION, AND IS NOT DESIGN RELATED. SURGICAL TECHNIQUE GUIDES FOR THE RIA SYSTEM INCORPORATE CLEAR AND EXPLICIT PRECAUTIONARY STATEMENTS REGARDING PATIENT RISK IF DEVICE IS NOT ASSEMBLED PROPERLY. DURING THE INVESTIGATION NO UNIDENTIFIED PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). (510K): UNKNOWN, AS SPECIFIC PART AND LOT NUMBERS FOR REAMING ROD IS NOT PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.
ADDITIONAL DEVICE PRODUCT CODE: HRX. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART #314.743, LOT #9895470: RELEASE TO WAREHOUSE DATE: MAR 7, 2016, EXPIRATION DATE: NA, SUPPLIER:(B)(4). NO NON CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION; REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS 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.
THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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.
ADDITIONAL NARRATIVE: PRODUCT WAS NOT RETURNED. THE RECEIVED PRODUCT PICTURES CONFIRM BROKEN/DAMAGED ITEMS. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DHR REVIEW SHOWED NO ISSUES, NO FURTHER INVESTIGATION POSSIBLE AS THERE WAS NO MATERIAL AVAILABLE. WITHOUT INVESTIGATION NO ROOT CAUSE CAN BE DEFINED. 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 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.
IT WAS REPORTED THAT TWO REAMER HEADS BROKE OFF AT THE PROXIMAL END. IN ADDITION, THE TIP OF THE REAMER/IRRIGATOR/ ASPIRATOR (RIA) SHAFT BROKE OFF AND THE REAMER HEAD (352.259) COULD NOT BE REMOVED FROM TUBE ASSEMBLIES. THIS HAPPENED INTRAOPERATIVELY ON (B)(6) 2017. NO PROLONGATION OF SURGERY WAS REPORTED AND NO INFORMATION ABOUT PATIENT OUTCOME. CONCOMITANT PART: 1X RIA REAMER HEAD Ø16.5, 352.259S / 9842342.
THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).
UPON RECEIPT OF THE DEVICES AT MANUFACTURER AND DURING PRELIMINARY INVESTIGATION OF THE RETURNED DEVICES, IT WAS IDENTIFIED THAT THE RIA REAMER HEAD WAS STUCK INSIDE THE TUBE ASSEMBLY AND NOT A DRILL BIT AS REPORTED BY COMPLAINANT.
DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A DRILL BIT AND A REAMING ROD BROKE INTRAOPERATIVELY ON (B)(6) 2017. NO PROLONGATION OF SURGERY WAS REPORTED AND NO INFORMATION ABOUT PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) UNKNOWN REAMING ROD. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). .
FURTHER IT WAS REPORTED THAT THE TIP OF THE REAMING ROD BROKE OFF AND THE DRILL BIT COULD NOT BE REMOVED FROM TUBE ASSEMBLIES. ADDITIONALLY TWO (2) REAMER HEADS BROKE OFF AT THE PROXIMAL END. THIS HAPPENED INTRAOPERATIVELY ON (B)(6)2017. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
REAMER HEAD WAS BENT BECAUSE IT WAS STUCK IN THE TUBE ASSEMBLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389220 | DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA | REAMER | HTO | SYNTHES MONUMENT | 9895470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |