NOVOSTITCH PRO MEN RPR SYS 2-0
Report
- Report Number
- 3009131204-2021-00001
- Event Type
- Injury
- Date Received
- January 7, 2021
- Date of Event
- December 17, 2020
- Report Date
- February 5, 2022
- Manufacturer
- CETERIX ORTHOPAEDICS, INC
- Product Code
- GAT
- UDI-DI
- 00853541006112
- PMA / PMN Number
- K180531
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
H3, H6: THE DEVICE WITH UNSPENT CARTRIDGE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. UPON INVESTIGATION, IT WAS DETERMINED THAT THE UPPER JAW LINK HAD BROKEN. IF THE LINK IS BROKEN, THE ORANGE TRIGGER CAN NO LONGER CONTROL THE UPPER JAW AND THE SURGEON WILL HAVE INCOMPLETE STITCH. IT WAS DETERMINED THE DEVICE DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE COMPLAINT WAS CONFIRMED AND THE ROOT CAUSE WAS ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. THE UPPER JAW LINK CAN BREAK WHEN EXCESSIVE FORCE IS APPLIED DURING USE, IF THE PORTAL PLACEMENT IS LOW, OR JAMMING THE DEVICE IN AND OUT OF THE KNEE OR INTO THE STRUCTURES IN KNEE. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW CONCLUDED THIS WAS A REPEAT ISSUE. A REVIEW OF RISK MANAGEMENT FILES FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.
LOT NUMBER M200063, ONE DEVICE WITH UNSPENT CARTRIDGE, USED IN TREATMENT, WAS RETURNED FOR EVALUATION. THERE WAS RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. UPON INVESTIGATION, IT WAS DETERMINED THAT THE UPPER JAW LINK HAD BROKEN. IF THE LINK IS BROKEN, THE ORANGE TRIGGER CAN NO LONGER CONTROL THE UPPER JAW AND THE SURGEON WILL HAVE INCOMPLETE STITCH. THE UPPER JAW LINK CAN BREAK WHEN EXCESSIVE FORCE IS APPLIED DURING USE, IF THE PORTAL PLACEMENT IS LOW, OR JAMMING THE DEVICE IN AND OUT OF THE KNEE OR INTO THE STRUCTURES IN KNEE. THE PROBABLE ROOT CAUSE FOR THE UPPER JAW LINK TO BREAK COULD BE DUE TO TORQUEING THE DEVICE EXCESSIVELY AND PLACING TOO MUCH FORCE ON THE HINGE AND UPPER JAW. THERE WERE NO INDICATIONS DURING MANUFACTURING RECORD REVIEW THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. RISK MANAGEMENT DOCUMENTS WERE REVIEWED FINDING NO ADDITIONAL RISKS THAT REQUIRE TO BE ADDED TO THE REFERENCE DOCUMENT. THE INSTRUCTION FOR USE (IFU) OUTLINES PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARD TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. A REVIEW OF THE COMPLAINT AND MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME.
VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED BECAUSE THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION. THUS, THE COMPLAINT COULD NOT BE VERIFIED, AND A ROOT CAUSE COULD NOT BE DETERMINED WITH CONFIDENCE. IT IS DIFFICULT TO PERFORM AN ACCURATE EVALUATION OF A FAILURE WITHOUT HAVING THE FAILED PRODUCT TO LOOK AT. AS SUCH THE COMPLAINT IS BEING CLOSED WITHOUT CONCLUSION. HOWEVER, IF THE PRODUCT IS RETURNED IN THE FUTURE THE COMPLAINT CAN BE REOPENED AND EVALUATED. OUR QUALITY DEPARTMENT WILL CONTINUE TO MONITOR FOR TRENDS. NO FURTHER INVESTIGATION IS REQUIRED. THE UPPER JAW HINGE CAN BREAK WHEN EXCESSIVE FORCE IS APPLIED DURING USE, IF THE PORTAL PLACEMENT IS LOW, OR JAMMING THE DEVICE IN AND OUT OF THE KNEE OR INTO THE STRUCTURES IN KNEE. THE PROBABLE ROOT CAUSE FOR THE UPPER JAW HINGE TO BREAK COULD BE DUE TO TORQUEING THE DEVICE EXCESSIVELY AND PLACING TOO MUCH FORCE ON THE HINGE AND UPPER JAW. A COMPLAINT HISTORY REVIEW FOUND NO RELATED FAILURES; THIS FAILURE MODE WILL BE TRENDED TO ASSESS FOR ANY NECESSARY CORRECTIVE ACTIONS. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE PROVIDED, THIS COMPLAINT WILL BE RE-ASSESSED. THE RISK MANAGEMENT DOCUMENTATION WAS REVIEWED AND FOUND TO CONTAIN THIS FAILURE MODE WITHIN THE RISK FILE, NO UPDATES ARE REQUIRED. THE INSTRUCTION FOR USE (IFU) OUTLINES PRECAUTIONARY STATEMENTS AND INSTRUCTIONS IN REGARD TO THE USE OF THE DEVICE TO AVOID DAMAGE OR NON-FUNCTIONALITY. A REVIEW OF THE COMPLAINT AND MANUFACTURING RECORDS WAS PERFORMED AND THERE WERE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. FURTHER INVESTIGATION IS NOT WARRANTED AT THIS TIME.
INTERNAL COMPLAINT REFERENCE (B)(4).
IT WAS REPORTED THAT DURING THE SURGERY, BOTH PRE-LOADED AND THE FIRST RELOADING CARTRIDGE HAD NO PROBLEMS PLACING THE SUTURE. THE OTHER RELOADING CARTRIDGE WAS PROPERLY INSERTED AND PLACED IN THE JOINT. WHEN ACTUATING THE UPPER JAW WITH THE ORANGE HANDLE, A SMALL METAL PART CAME LOOSE. IT WAS NOT POSSIBLE TO IDENTIFY IF THE METAL PIECE WAS FROM THE INSTRUMENT OR THE RE-LOADING CARTRIDGE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT¿S ANATOMY. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26593 | NOVOSTITCH PRO MEN RPR SYS 2-0 | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | GAT | CETERIX ORTHOPAEDICS, INC | CTX-A003 | M200063 | 00853541006112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |