TI USS LOW PROFILE FRACTURE CLAMP
Report
- Report Number
- 2520274-2015-14707
- Event Type
- Malfunction
- Date Received
- June 29, 2015
- Report Date
- June 16, 2015
- Manufacturer
- SYNTHES MEZZOVICO
- Product Code
- NKB
- PMA / PMN Number
- PK082572
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
MANUFACTURING INVESTIGATION EVALUATION: THE RETURNED PARTS WERE RETURNED NOT IN THE ORIGINAL NOT STERILE PACKAGING. SOME VISIBLE POST-PRODUCTION DAMAGES WERE PRESENT ON THE RETURNED ITEMS. THE PARTS HAVE BEEN RE-INSPECTED FOR ALL THE FEATURES PERTINENT TO THE COMPLAINT CONDITION. CONSIDERING THAT ALL RELEVANT MEASURABLE PRODUCT FEATURES MEET SPECIFICATIONS, NO VISUAL DEFECTS HAVE BEEN IDENTIFIED AS MANUFACTURING RELATED. INSPECTION OF THE RELEVANT THREADS OF THE COMPLAINED COMPONENT CANNOT BE PERFORMED DUE TO POST-PRODUCTION DAMAGES. THE SCREWS OF ALL RETURNED PARTS SHOW WEAR ON THE TIP, SUGGESTING THAT THEY CAME IN CONTACT WITH THE ROD. THE EXAGONAL HEAD OF THE RETURNED SCREWS SHOW WEAR AND DAMAGE CAUSED POST-PRODUCTION SUGGESTING EXPOSURE TO HIGH FORCES. NO MANUFACTURING RELATED ISSUES HAVE BEEN IDENTIFIED. DEVICE 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. PATIENT INFORMATION NOT PROVIDED. REPORT IS FOR AN UNKNOWN QUANTITY OF TITANIUM USS FRACTURE CLAMPS ¿ TWO POSSIBLE PART NUMBERS WERE PROVIDED: 498.831 OR 498.833. 510(K) NUMBER FOR P/NS 498.831 AND 498.833 : K082572. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ADDITIONAL PRODUCT CODES: MNI, MNH, KWP, KWQ. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 23JANUARY2015. NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 IS REPORT 1 OF 3 FOR (B)(4).
IT WAS REPORTED DURING A L2 TRAUMA FRACTURE PROCEDURE, THE SURGEON WAS INSERTING THE CLAMP FOR DISTRACTION AT L2. REPORTEDLY THE SURGEON CLAIMS THAT THE GOLD BOLT ON THE TITANIUM USS FRACTURE CLAMPS (498.831 OR 498.833) CONTINUES TO STRIP AFTER HIS FIRST ATTEMPT OF ¿WHITE KNUCKLE¿ TIGHTENING. THE SURGEON REPORTED THAT THIS HAS OCCURRED IN BACK TO BACK CASES WHILE THE SURGEON IS DISTRACTING. REPORTEDLY THE SURGEON WAS ABLE TO REMOVE THE CLAMP, SELECT A NEW CLAMP AND COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THERE WAS A 20 MINUTE DELAY TO THE SURGERY. SURGEON INSERTED SCREWS TWO LEVELS ABOVE AND BELOW L2. THE SURGEON WOULD LIKE TO KNOW MANUFACTURING DIFFERENCE OF THE CLAMP PRE/POST-MERGER AS HE HAS USED THIS SYSTEM FOR 20+ YEARS AND HAVE NEVER EXPERIENCED THIS TROUBLE UNTIL RECENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418951 | TI USS LOW PROFILE FRACTURE CLAMP | ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD | NKB | SYNTHES MEZZOVICO | 9340956 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |