TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
Report
- Report Number
- 1719045-2017-10226
- Event Type
- Malfunction
- Date Received
- March 16, 2017
- Date of Event
- February 18, 2017
- Report Date
- February 20, 2017
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- JEY
- PMA / PMN Number
- K083388
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
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.
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM, PART NUMBER 04.503.206.01C, LOT NUMBER H251170). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: WE HAVE RECEIVED THE TWO (2) SCREWS Ø1.5 SELF-TAP L6 TAN 1U I/CLIP (04.503.206.01C / H251170) FOR INVESTIGATION, HERE IS THE STATEMENT: UPON VISUAL INSPECTION, WE HAVE RECEIVED SMALL PLASTIC BAG WITH FRAGMENTS FROM SCREWS: - THE FIRST SCREW IS BROKEN (BELOW THE HEAD) IN TWO PIECES (HEAD AND SHANK PART), THE SCREW RECESS AND THE TIP ARE IN USED BUT GOOD CONDITION. - FROM THE SECOND SCREW WE HAVE RECEIVED TWO FRAGMENTS OF THE SCREW HEAD, THE REST OF THE SCREW IS MISSING. - FROM THE THIRD SCREW WE HAVEN¿T RECEIVED ANY PIECES OR FRAGMENTS. - CONCERNING, THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT, 120 PARTS WERE DELIVERED TO THE WAREHOUSE, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. THE ARTICLE WAS MANUFACTURED IN DECEMBER 2016. NO NCRS WERE MARKED IN THE DHR DURING PRODUCTION. THE RAW MATERIAL CERTIFICATES WERE CHECKED AND IT WAS FOUND THAT ALL USED RAW MATERIAL FULFILLED THE SPECIFICATIONS. MOREOVER, A REVIEW OF OUR COMPLAINTS DATA BASE SHOWS, THAT THERE ARE NO OTHER COMPLAINTS FOR THIS ISSUE FROM THIS ARTICLE AND LOT NUMBER. FINAL INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. FIRST SCREW: THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DAMAGE. SECOND SCREW: THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE SMALL FRAGMENTS. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT WE HAVE TO ASSUME THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE AND/OR MECHANICAL FORCE LED TO THIS DAMAGE. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY TO OPERATE ACCORDING TO THE TECHNIQUE GUIDE, PAGE 10 ¿WARNINGS: THESE DEVICES CAN BREAK DURING USE (WHEN SUBJECTED TO EXCESSIVE FORCES OR OUTSIDE THE RECOMMENDED SURGICAL TECHNIQUE). WHILE THE SURGEON MUST MAKE THE FINAL DECISION ON REMOVAL OF THE BROKEN PART BASED ON ASSOCIATED RISK IN DOING SO, WE RECOMMEND THAT WHENEVER POSSIBLE AND PRACTICAL FOR THE INDIVIDUAL PATIENT, THE BROKEN PART SHOULD BE REMOVED.¿). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
(B)(4). DUE TO THE INTRA-OPERATIVE EVENTS, THE DEVICE WAS NOT SUCCESSFULLY IMPLANTED. AN ALTERNATE DEVICE WAS USED TO COMPLETE PROCEDURAL STEP. AS SUCH, IMPLANT/EXPLANT DATES ARE NOT APPLICABLE. (B)(6). THE SUBJECT DEVICE IS CURRENTLY UNDERGOING INVESTIGATION; THE RESULTS ARE PENDING COMPLETION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: DEC 8, 2016. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
ONE SCREW COULD BE REMOVED ENTIRELY IN TWO PIECES AND ONE SCREW COULD BE REMOVED ENTIRELY IN FRAGMENTS. THE THIRD SCREW COULD NOT BE REMOVED AND STILL REMAINS INTO PATIENT'S BODY BETWEEN THE PLATE AND THE BONE.
DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2017, THREE (3) MATRIX MIDFACE SCREWS BROKE DURING INSERTION. TWO (2) OF THE BROKEN SCREWS WERE ABLE TO BE REMOVED ENTIRELY; THE FIRST BROKE INTO TWO (2) PIECES, THE SECOND BROKE INTO SEVERAL FRAGMENTS. THE THIRD BROKEN SCREW BODY WAS RETAINED IN THE PATIENT BETWEEN THE PLATE AND THE PATIENT¿S BONE WITH THE TIP IN THE PATIENT¿S BONE. THE FRAGMENTS OF THE THIRD SCREW COULD NOT BE REMOVED. THE SURGERY WAS DELAYED BY 20 MINUTES DUE TO THE REPORTED EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY AS THE SURGEON REDUCED AND STABILIZED THE FRACTURE. THE PATIENT¿S POSTOPERATIVE OUTCOME WAS STABLE. REPORTED CONCOMITANT DEVICES: SCREW SELF-TAPPING (PART: 04.503.206.01C, LOT: H282478, QUANTITY: 12), SCREW SELF-DRILLING (PART: 04.503.226.01C, LOT: H261237, QUANTITY: 4), MATRIX MIDFACE ADAPTION PLATE: (PART: 04.503.376, LOT: H251265, QUANTITY: 1), DRILL BIT: (PART: 317.260, LOT: F-20360, QUANTITY: 1). THIS REPORT IS 1 OF 3 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192748 | TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM | BONE, PLATE | JEY | SYNTHES MONUMENT | H251170 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 04.503.206.01C,TI MATRIXMIDFACE SCR 6MM, QTY 12| 04.503.226.01C, TI MATRIXMIDFACE SCR 6MM, QTY 4| 04.503.376, TI MATRIXMIDFACE ADAP PLATE/20 HOLES| 317.260, 1.1MM DRILL BIT/MINI QC WITH 6MM STOP/44. |