TI SNAP-ON TRANSCONNECTOR 47MM-62MM FOR 5.5MM/6.0MM RODS
Report
- Report Number
- 8030965-2019-62350
- Event Type
- Injury
- Date Received
- March 29, 2019
- Report Date
- April 18, 2019
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- NKB
- UDI-DI
- 07611819366305
- PMA / PMN Number
- K100952
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: PART: 04.633.347S; LOT: L309927; MANUFACTURING LOCATION: SELZACH; SUPPLIER: FRUEH AG; RELEASE TO WAREHOUSE DATE: FEBRUARY 01, 2017; EXPIRY DATE: JANUARY 01, 2027 NON-STERILE 04.633.347 / H263446 WAS MANUFACTURED IN US, ELMIRA PART: 04.633.347; LOT: H263446; PART MANUFACTURING DATE: JANUARY 09, 2017; PART EXPIRATION DATE: N/A A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT H263446 OF TI SNAP-ON TRANSCONNECTORS WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE COMPONENT DEVICE HISTORY RECORD(S) DETERMINED THE COMPONENT LOTS H214804, H233337, H243648, H250895, H253831, H254921, H255017, H255313, H258679, AND H259323 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. LOT H251705 WAS USED FOR SALEABLE PROCESS TEST. THIS TEST MET ALL ACCEPTANCE CRITERIA WITH NO EXCEPTIONS OR DEFECTS NOTED, SO THIS TEST IS DETERMINED TO HAVE NO IMPACT ON THE COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD(S) DETERMINED THE RAW MATERIAL LOTS H041400 AND H163396 MET ALL SPECIFICATIONS WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: SNAP-ON TRANSVERSE CONNECTOR L47-62 F/R Ø WAS RECEIVED AT CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE IMPLANT SHOWED THAT THE DEVICE WAS TAKEN APART AND FRACTURED AT THE T-ROD JUNCTION. MATERIAL SURFACE AT THE FRACTURE SITE APPEARS HOMOGENEOUS WITH NO VOIDS OR ABNORMALITIES WHEN VIEWED UNDER 10X MAGNIFICATION AT CQ. THE BALANCE OF THE DEVICE IS IN FAIR CONDITION WITH SIGNS OF IMPLANTATION AND EXPLANATION. THE RECEIVED CONDITION DOES AGREE WITH THE COMPLAINT DESCRIPTION FOR BROKEN AND IS CONFIRMED. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED TO BE USE ERROR, MISUSE/ABUSE, NONCOMPLIANCE, POSTOPERATIVE TRAUMA. DOCUMENT / SPECIFICATION REVIEW: THE FOLLOWING DRAWINGS WERE REVIEWED DURING INVESTIGATION: - ARCHED DUAL ARTICULATING TI TRANCONNECTOR - C-CHANNEL ARCHED DUAL ARTICULATING DIMENSIONAL INSPECTION: THE DIAMETER OF THE ROD AT THE POINT OF FRACTURE WAS INTENDED TO BE 3.9MM TO 4.1MM AND WAS MEASURED TO BE WITHIN SPECIFICATION. DEVICE HISTORY RECORD (DHR) REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS LOT H263446 OF TI SNAP-ON TRANS CONNECTORS WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMANCES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE DEVICE BREAKAGE COULD NOT BE DETERMINED FROM THE PROVIDED INFORMATION. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. 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.
CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: UNKNOWN), UNKNOWN RODS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).
ADDITIONAL PROCODES: MNH, MNI, KWQ, KWP. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY FOR A THORACIC LUMBAR SPINE FUSION USING GENERAL ANESTHESIA DUE TO A BROKEN UNKNOWN ROD ON THE LEFT SIDE. INITIALLY, THE PATIENT HAD THE PRIMARY SURGERY ON (B)(6) 2017. AFTER THE SURGERY, THE SURGEON RECOGNIZED THE REPORTED LEFT SIDE UNKNOWN ROD WAS BROKEN. THIS OCCURRED AT L5-S1 IN BETWEEN THE SNAP-ON TRANSVERSE CONNECTORS WHICH WERE BROKEN APART. THE ROD WAS CUT BETWEEN L3 AND L4 AND THE ROD BETWEEN L4 AND S2 WAS REMOVED. A NEW UNKNOWN SCREW WAS IMPLANTED AND L5-L2 WAS FIXED WITH A NEW UNKNOWN ROD. UNKNOWN ANGLE CONNECTORS WERE IMPLANTED BETWEEN L2-L3 AND L5-S1. A PEDICLE SUBTRACTION OSTEOTOMY WAS PERFORMED ON L4. BOTH LEFT AND RIGHT UNKNOWN OFFSET ANGLE CONNECTORS WERE CONNECTED TO EACH OTHER IN THE SUPERIOR SIDE. AN UNKNOWN TRANSVERSE CONNECTOR WAS IMPLANTED BETWEEN THE RODS AT L4. THE PATIENT IS CURRENTLY HOSPITALIZED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT CONSEQUENCE IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) TI SNAP-ON TRANSCONNECTOR 47MM-62MM FOR 5.5MM/6.0MM RODS. THIS IS REPORT 1 OF 1 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 257691 | TI SNAP-ON TRANSCONNECTOR 47MM-62MM FOR 5.5MM/6.0MM RODS | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD | NKB | OBERDORF SYNTHES PRODUKTIONS GMBH | L309927 | 07611819366305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |