THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM
Report
- Report Number
- 0001032347-2018-00199
- Event Type
- Malfunction
- Date Received
- April 16, 2018
- Date of Event
- March 1, 2018
- Report Date
- September 25, 2018
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- GWO
- PMA / PMN Number
- PK121624
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE FOLLOWING SECTIONS WERE CORRECTED: ADVERSE EVENT: BASED ON THE UPDATED/CORRECTED INFORMATION NO ADVERSE EVENT OCCURRED. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES): BASED ON THE UPDATED/CORRECTED INFORMATION THERE WAS NO INTERVENTION. BRAND NAME CORRECTED FROM "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR, 5/PK 1.5MM X 4MM TO THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM. CATALOG NUMBER CORRECTED FROM 95-6104 TO 91-6704. UNIQUE IDENTIFIER (UDI) # CORRECTED FROM (B)(4) TO (B)(4). DEVICE CODE(S) CORRECTED FROM JEY TO GWO. PMA/510(K) NUMBER CORRECTED FROM K121589 TO K121624. TYPE OF REPORTABLE EVENT CORRECTED FROM SERIOUS INJURY TO MALFUNCTION.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE SCREW WAS VISUALLY EVALUATED AND FOUND TO HAVE MINOR DAMAGE ON THE CROSS-DRIVE AREA OF THE HEAD THAT INTERFACES WITH THE BLADE, INDICATING THE BLADE RETAINED THE SCREW WHEN TORQUE WAS APPLIED. THERE IS DEFORMATION TO THE TIP FROM AN ATTEMPT TO INSERT THE SCREW. THE PART DIMENSIONS CANNOT BE ACCURATELY MEASURED DUE TO THE DAMAGE FROM THE ATTEMPT TO INSERT THE SCREW; ANY MEASUREMENTS WOULD NOT BE REPRESENTATIVE OF THE SCREW BEFORE USE. THE SCREW WAS FUNCTIONALLY TESTED BY INSERTING THE SCREW INTO A WHITE OAK BLOCK. THE SCREW WAS ABLE TO BE RETAINED ON THE BLADE AND WAS FULLY INSERTED INTO THE WHITE OAK BLOCK WITH SOME DIFFICULTY WITH INITIAL PURCHASE. THE COMPLAINT WAS NON-VERIFIABLE AS THE SCREW WAS DAMAGED FROM USE AND COULD NOT BE DIMENSIONALLY EVALUATED IN ITS RETURNED CONDITION; HOWEVER, THE SCREW WAS ABLE TO BE FULLY SEATED INTO A WHITE OAK BLOCK WITH SOME DIFFICULTY. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
UPON RECEIPT OF THE DEVICE FOR EVALUATION IT WAS IDENTIFIED THE DEVICE DID NOT MATCH THE PICTURE AND EVENT REPORTED BY THE DISTRIBUTOR. CORRECTED INFORMATION WAS PROVIDED, THE TIP OF THE SCREW WAS DULL, IT DID NOT FRACTURE. THE DEVICE INFORMATION WAS UPDATED.
(B)(4). (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED DURING A "CROSSING TECHNIQUE" PROCEDURE THE TIP OF A SCREW BROKE. THE PROCEDURE WAS COMPLETED USING A SCREW OF THE SAME SIZE. THE PATIENT DID NOT RETAIN A FOREIGN BODY AND THERE WAS A DELAY OF LESS THAN TEN MINUTES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 274908 | THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM | BONE SCREW | GWO | BIOMET MICROFIXATION | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |