3.5MM TI LCP® RECONSTRUCTION PLATE 8 HOLES/112MM
Report
- Report Number
- 2520274-2017-11950
- Event Type
- Injury
- Date Received
- July 21, 2017
- Report Date
- June 22, 2017
- Manufacturer
- SYNTHES RARON
- Product Code
- KTT
- PMA / PMN Number
- K000684
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
. OUT OF TOTAL 9 SCREWS REPORTED AS CONCOMITANT IT IS UNKNOWN WHICH SCREW BACKED OUT/ PULL OUT POSTOPERATIVELY. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON PART # 445.081-EXS / L114248: MANUFACTURING LOCATION: RARON, MANUFACTURING DATE: 12. SEPT. 2016: 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 THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A MANUFACTURING INVESTIGATION WAS PERFORMED. THE PLATE IS BROKEN. MARKS AND SCRATCHES ARE VISIBLE ON THE SURFACE. THE DEVICE-HISTORY-RECORD (DHR) DOES NOT SHOW ANY ABNORMALITIES. EVERYTHING WAS PRODUCED IN SPECIFICATION AS IT SHOULD. MEASUREMENTS OF THE CRITICAL FEATURES WERE TAKEN ON THE COMPLAINT PART. THIS CONFIRMED THE RESULTS OF THE DHR. THE PLATE (LCP RECON PLATE 3.5 STRAIGHT W/COMBINED HOLE / ARTICLE # 445.081 / LOT # L114248) WAS PRODUCED AS IT SHOULD. NO ABNORMALITY IN PROCESS WAS FOUND. BASED ON THIS, THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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.
A MANUFACTURING INVESTIGATION WAS PERFORMED. THE PLATE IS BROKEN THROUGH THE 5TH HOLE. IN GENERAL PLATE IS DEFORMED IN MANY AREAS. THE MARKS ON THE SIDE OF THE PLATE INDICATE THAT THE PLATE HAS BEEN RESHAPED AND REFORMED IN ORDER TO FIT THE PATIENT. HOLE 5 IS NOT MEASURABLE FOR FEATURE DUE TO THE BREAKAGE IN HOLE 5. HOLE 8 IS ALSO NOT MEASURABLE FOR FEATURES DUE DEFORMATION AROUND IT. WIDTH OF THE PLATE, THICKNESS OF THE PLATE, HOLE DIAMETER, HOLE SYMMETRY, THREAD ZERO POINT AND BALL HEIGHT OF HOLES WERE MEASURED AND FOUND TO BE WITHIN SPECIFICATION. THE CRITICAL FEATURES WERE VERIFIED ON THE COMPLAINT PART. ALL MEASUREMENTS TAKEN ALIGN WITH THE RESULTS ON THE TESTS AND MEASUREMENTS PERFORMED DURING PRODUCTION. THE PLATE IS MANUFACTURED OUT OF THE FOLLOWING RAW-MATERIAL: PROFILE 10.1 X 3.1MM TICP ANP/ ARTICLE # (B)(4)/ LOT # 18731. IT IS FOUND TO BE WITHIN SPECIFICATION. BASED ON THIS, THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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 DEVICES: THE NINE (9) SCREWS WERE RETURNED AS CONCOMITANT DEVICES WITHOUT AN ALLEGED COMPLAINT CONDITION. UPON VISUAL INSPECTION, THERE IS NO EVIDENCE THAT THESE DEVICES CONTRIBUTED TO THE COMPLAINT CONDITION, AND THEREFORE NO ADDITIONAL INVESTIGATION WILL BE PERFORMED. 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.
THIS REPORT IS FOR ONE (1) UNKNOWN PLATE. PART#, LOT# AND UDI # IS NOT AVAILABLE. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4). THIS REPORT IS FOR ONE (1) UNKNOWN PLATE. PMA/510(K) NUMBER IS NOT AVAILABLE. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT 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.
CONCOMITANT MEDICAL PRODUCTS: 3.5MM TI CORTEX SCREW SELF -TAPPING 16MM (PART # 404.816, LOT # L252102, QUANTITY 1), 3.5MM TI CORTEX SCREW SELF -TAPPING 16MM (PART # 404.816, LOT # L080949, QUANTITY 1), 4.0MM TI CANCELLOUS BONE SCREW FULLY THREADED/14MM (PART # 406.014, LOT # 9705649, QUANTITY 1), 3.5MM TI CORTEX SCREW SELF -TAPPING 20MM (PART # 404.820, LOT # L207121, QUANTITY 1), 3.5MM TI CORTEX SCREW SELF -TAPPING 18MM (PART # 404.818, LOT # 9884615, QUANTITY 1), 3.5MM TI LOCKING SCREW SELF-TAPPING 18MM (PART # 413.018, LOT # L233822, QUANTITY 1), 3.5MM TI LOCKING SCREW SELF-TAPPING 16MM (PART # 413.016, LOT # L243053, QUANTITY 1), 3.5MM TI LOCKING SCREW SELF-TAPPING 16MM (PART # 413.016, LOT # L258928, QUANTITY 1), 3.5MM TI LOCKING SCREW SELF-TAPPING 22MM (PART # 413.022, LOT # 9811893, QUANTITY 1), PDS CERCLAGE (PART & LOT# UNKNOWN, QUANTITY 1).THIS REPORT IS FOR ONE (1) 3.5MM TI LCP RECONSTRUCTION PLATE 8 HOLES/112MM
THE PATIENT EXPERIENCED NUMBNESS AND DECREASED STRENGTH IN THE RIGHT HAND AREA TWO DAYS PRIOR TO ACUTE ADMISSION. THE PATIENT PRESENTED TO THE SURGEON'S OFFICE ON (B)(6), 2017 WITH X-RAY IMAGES REVEALING THE REFRACTURE OF THE CLAVICLE, BROKEN PLATE AND ONE OF THE INTERFRAGMENTARY TRACTION BOLTS SHOWN REMOVED FROM THE ASSEMBLY AND LYING IN THE GAP OF THE FRACTURE (X-RAY RESULTS REPORTED ABOVE). THE PATIENT'S NEUROLOGICAL DIAGNOSIS WAS MIDDLE TO LOWER PLEXUS LESION WHICH WAS THE INDICATION FOR DIRECT ADMISSION TO THE HOSPITAL AND SUBSEQUENT REVISION SURGERY THE SAME DAY. IT WAS REPORTED THAT BESIDES REMOVING ALL OF THE EXISTING HARDWARE, THE PATIENT UNDERWENT A DEBRIDEMENT OF THE CONNECTIVE TISSUE CALLUS, RE-OSTEOSYNTHESIS WITH A COMPETITOR'S PLATE AND FILLING OF THE DEFECT WITH AUTOLOGOUS CANCELLOUS BONE EXTRACTED FROM THE IPSILATERAL TUBERCULUM MAJUS. THE CANCELLOUS BONE WAS MIXED WITH 5 X 5CM GENTOCOLL FLEECE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017 WITH A MANAGEABLE PAIN LEVEL.
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OSTEOSYNTHETIC TREATMENT OF A MULTIPLE FRAGMENT FRACTURE OF THE RIGHT CLAVICLE. PATIENT WAS IMPLANTED WITH TWO (2) INTERFRAGMENTARY SCREWS, A RECONSTRUCTION PLATE, AND A PDS CERCLAGE WAS INTRODUCED. POSTOPERATIVE, IN THE COURSE OF TIME, PATIENT COMPLAINED ABOUT INCREASING PAIN AND LIMITATION OF MOVEMENT IN THE RIGHT SHOULDER AREA WITHOUT NEW TRAUMA. THEN, THE PATIENT EXPERIENCED NUMBNESS AND DECREASED STRENGTH IN THE RIGHT HAND AREA. POSTOPERATIVE X-RAY TAKEN ON AN UNKNOWN DATE SHOWED A REFRACTURE OF THE CLAVICLE AND THE BREAKAGE OF THE PLATE IN THE AREA OF THE FRACTURE. ADDITIONALLY, ONE OF THE INTERFRAGMENTARY TRACTION BOLTS WAS SHOWN REMOVED FROM THE ASSEMBLY, LYING IN THE GAP OF THE FRACTURE. ON (B)(6) 2017, PATIENT UNDERWENT REVISION SURGERY. DURING THE REVISION SURGERY, THE MATERIAL WAS COMPLETELY REMOVED AND PATIENT WAS IMPLANTED WITH NON-SYNTHES IMPLANTS. THERE WERE NO POST-OPERATIVE COMPLICATIONS. THE PATIENT COMPLAINED LESS ABOUT DECREASED STRENGTH AND HYPOSENSITIVITY. THE POST-OPERATIVE X-RAY CONTROL SHOWED THE PROPER RESULTS OF THE OPERATION WITH A MATERIAL POSITION THAT DID NOT CAUSE IRRITATION; THE X-RAY SHOWED NO ABNORMALITIES OF THE RIGHT SHOULDER FOLLOWING EXTRACTION OF CANCELLOUS BONE. CONCOMITANT REPORTED DEVICES: SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), PDS CERCLAGE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) UNKNOWN PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 513203 | 3.5MM TI LCP® RECONSTRUCTION PLATE 8 HOLES/112MM | APPLIANCE, FIXATION, NAIL | KTT | SYNTHES RARON | L114248 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ONE (1) UNKNOWN PDS CERCLAGE| ONE (1) UNKNOWN SCREW |