5.5 EXP VERSE SCR 6.0X50
Report
- Report Number
- 1526439-2020-01728
- Event Type
- Malfunction
- Date Received
- September 18, 2020
- Date of Event
- September 4, 2020
- Report Date
- September 4, 2020
- Manufacturer
- MEDOS INTERNATIONAL SÃ RL CH
- Product Code
- NKB
- UDI-DI
- 10705034444048
- PMA / PMN Number
- K142185
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED: INVESTIGATION FLOW: FUNCTIONAL/DEVICE INTERACTION VISUAL INSPECTION: THE 5.5 EXP VERSE SCREW 6.0 X 50 (P/N: 199721650, LOT NUMBER: 253868) WAS RECEIVED AT US CQ. VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THE HEAD OF THE SCREW WAS LOCKED IN THE MONOAXIAL POSITION. PER THE SYSTEM GUIDE, THE POLYAXIAL SCREW CONVERTS TO A MONOAXIAL SCREW UPON TIGHTENING OF THE SET SCREW. THE SYSTEM GUIDE INDICATES THAT EXCEEDING THE SYSTEM TORQUE MAY RESULT IN FAILURE OF THE IMPLANT. UPON LOOSENING OF THE SET SCREW, THE SCREW HEAD SHOULD BECOME MOBILE AGAIN. THE THREADS OF THE SCREW HEAD WERE OBSERVED TO BE STRIPPED. THE TABS ON THE SCREW HEAD WERE OBSERVED TO BE BROKEN. THESE TABS WERE DESIGNED TO BE BROKEN AND DO NOT CONTRIBUTE TO THE COMPLAINT CONDITION. NO OTHER ISSUES WERE IDENTIFIED. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED ON THE COMPLAINT DEVICE. A 5.5 EXP VERSE UNITIZED SET SCR (PRODUCT CODE: 199721001, LOT NO.: XD2132) WAS USED TO PERFORM THE FUNCTIONAL TEST AND THE COMPLAINT COULD BE REPLICATED. THE SET SCREW WAS UNABLE TO BE FULLY LOCKED INTO THE SCREW HEAD AS THE THREADS OF THE SCREW HEAD WERE STRIPPED. THE 5.5 EXP VERSE UNITIZED SET SCR (PRODUCT CODE: 199721001, LOT NO.: XD2132) USED TO PERFORM THE FUNCTIONAL TEST IS BEING INVESTIGATED. ADDITIONALLY, THE HEAD OF THE SCREW WAS UNABLE TO BE MOVED FROM THE RECEIVED POSITION. THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: A DIMENSIONAL INSPECTION WAS NOT PERFORMED DUE TO THE DEVICE'S RECEIVED CONDITION. DOCUMENT/SPECIFICATION REVIEW: NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. THE COMPLAINT IS CONFIRMED. INVESTIGATION CONCLUSION: THIS COMPLAINT IS CAN BE CONFIRMED FOR 5.5 EXP VERSE SCREW 6.0 X 50 (P/N: 199721650, LOT NUMBER: 253868). NO DEFINITIVE ROOT CAUSE COULD BE IDENTIFIED. THE POSSIBLE ROOT CAUSE FOR THE STRIPPED THREADS COULD BE, APPLICATION OF UNINTENDED FORCES ON THE DEVICE, AND THE SCREW BEING LOCKED IN THE MONOAXIAL POSITION COULD BE OVER-TORQUING OF THE SET SCREWS. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT THE DHR OF PRODUCT CODE 199721650, LOT 253868, WAS REVIEWED AND NO NON-CONFORMANCE WAS OBSERVED DURING THE MANUFACTURING PROCESS. THE PRODUCT WAS RELEASED ON AUGUST 30, 2019. QTY. 399 THE DHR WAS ELECTRONICALLY REVIEWED. 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.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H10: ADDITIONAL NARRATIVE: D4: LOT NUMBER. 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 CODES: KWP;KWQ;MNH;MNI;OSH. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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. 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 ON (B)(6) 2020, WHILE USING THE EXPEDIUM VERSE FOR A 2 LEVEL TLIF. EVERYTHING WAS GOING AS PLANNED UNTIL THE FINAL TIGHTENING. AS THE SURGEON TIGHTENED THERE WAS A CLICK NOISE THAT WAS NOT THE USUAL TORQUE LIMITING CLICK. THE SURGEON USED THE CORRECTION KEY LOCKING CAPS. THE SET SCREW WAS SPINNING FREELY WITH THE CAP ATTACHED AND FULLY SEATED IN THE DRIVE MECHANISM. AS THE SCREW WAS BACKED OUT METAL SHARDS WERE COMING OFF THE SCREW TULIP. THIS HAPPENED MULTIPLE TIMES AND WASTED 6 SCREWS AND COUNTLESS LOCKING CAPS. THE FRAGMENTS GENERATED WERE EASILY REMOVED. X-RAYS WERE TAKEN TO CONFIRM THAT NO METAL FRAGMENTS REMAINED IN THE PATIENT. THERE WAS A SIXTY (60) MINUTE SURGICAL DELAY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM/CONSEQUENCE. CONCOMITANT DEVICES REPORTED: FINAL TIGHTENER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), ROD (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 5.5 EXP VERSE SCR 6.0X50 (PART NUMBER 199721650S, LOT UNKNOWN, QUANTITY 2), 5.5 EXP VERSE SCR 6.0X45 (PART NUMBER 199721645S, LOT UNKNOWN, QUANTITY 3), VERSE CORRECTION KEY (PART NUMBER 199721000, LOT UNKNOWN, QUANTITY 4). THIS REPORT INVOLVES ONE (1) 5.5 EXP VERSE SCR 6.0X50. THIS IS REPORT 1 OF 10 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1018674 | 5.5 EXP VERSE SCR 6.0X50 | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD | NKB | MEDOS INTERNATIONAL SÃ RL CH | 253868 | 10705034444048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | 5.5 EXP VERSE SCR 6.0X45| 5.5 EXP VERSE SCR 6.0X45| 5.5 EXP VERSE SCR 6.0X45| 5.5 EXP VERSE SCR 6.0X50| 5.5 EXP VERSE SCR 6.0X50| UNKNOWN RODS| UNKNOWN TIGHTENER| VERSE CORRECTION KEY| VERSE CORRECTION KEY| VERSE CORRECTION KEY| VERSE CORRECTION KEY| 5.5 EXP VERSE SCR 6.0X45| 5.5 EXP VERSE SCR 6.0X45| 5.5 EXP VERSE SCR 6.0X45| 5.5 EXP VERSE SCR 6.0X50| 5.5 EXP VERSE SCR 6.0X50| UNKNOWN RODS| UNKNOWN TIGHTENER| VERSE CORRECTION KEY| VERSE CORRECTION KEY| VERSE CORRECTION KEY| VERSE CORRECTION KEY |