2.4MM X 20MM TIGER CANNULATED SCREW
Report
- Report Number
- 3007420745-2019-00054
- Event Type
- Injury
- Date Received
- December 23, 2019
- Date of Event
- November 27, 2019
- Report Date
- November 27, 2019
- Manufacturer
- TRILLIANT SURGICAL
- Product Code
- HWC
- UDI-DI
- 00812926020778
- PMA / PMN Number
- K153338
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 117
Narratives
--NOTES TO FORM 3500A AND JUSTIFICATION FOR INFORMATION NOT PROVIDED (IN INITIAL OR FOLLOW-UP SUBMISSION) AS REQUIRED PER 21CFR803.52 IS BELOW. TRILLIANT SURGICAL ATTEMPTED TO OBTAIN THE OMITTED INFORMATION (ITEMS 1-11 BELOW) AS PART OF INTERNAL COMPLAINT HANDLING ACTIVITIES. 1. PATIENT DATE OF BIRTH (A2) AND WEIGHT (A4) NOT REPORTED. 2. DATE OF EVENT (B3) IS UNKNOWN. THE EVENT IS CONSIDERED TO BE WHEN THE SCREW STARTED TO PROTRUDE. 3. CATALOG # AND SERIAL # (D4) NOT UTILIZED BY TRILLIANT SURGICAL. 4. EXPIRATION DATE (D4) NOT APPLICABLE (N/A) TO NON-STERILE TRILLIANT SURGICAL PRODUCTS. 5. LOT # AND UNIQUE IDENTIFIER (UDI) # (D4) COULD NOT BE CONFIRMED. 6. IMPLANTED DATE (D6) UNKNOWN. 7. REPROCESSOR NAME AND ADDRESS (D9) N/A TO THIS REPORT. 8. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (D11) NOT REPORTED. 9. DEVICE MANUFACTURE DATE (H4) COULD NOT BE CONFIRMED. 10. SECTION H9 N/A TO THIS REPORT. 11. NO FILES ATTACHED TO THIS REPORT. --CORRECTED INFORMATION PROVIDED IN FOLLOW-UP SUBMISSION: B3; B4; B5 - DESCRIPTION OF EVENT OF PROBLEM WAS EDITED TO NOT IDENTIFY ANY PHYSICIANS OR FACILITIES BY NAME. B6; B7 ; D1; D2 - COMMON DEVICE NAME (PRODUCT CODE WAS CORRECT IN INITIAL SUBMISSION.); D4 - CATALOG #, SERIAL #, LOT #, UNIQUE IDENTIFIER (UDI) #; D6; D9; E4 ; SECTION F IS N/A TO THIS REPORT. G5; H1; H6 - PREVIOUS CODES ARE ALL ACCEPTABLE, BUT ADDITIONAL CODES HAVE BEEN ADDED. CODE 1395 FOR DEVICE CODE IS REPEATED FROM THE INITIAL SUBMISSION AS H6 MUST HAVE AT LEAST ONE VALID DEVICE PROBLEM CODE PER THE FDA. H7; H9 ; H10 - CORRECTED DATA. --ADDITIONAL INFORMATION PROVIDED IN FOLLOW-UP SUBMISSION G1 - NAME (AND EMAIL ADDRESS, TELEPHONE) UPDATED AS DIFFERENT PERSONNEL IS SUBMITTING THE FOLLOW-UP SUBMISSION THAN SUBMITTED THE INITIAL SUBMISSION. G7. H2. H10 - ADDITIONAL MANUFACTURER NARRATIVE. DHR REVIEW (SHALL REPLACE DHR REVIEW SECTION IN ORIGINAL SUBMISSION): POTENTIAL LOT NUMBERS COULD NOT BE IDENTIFIED. AFTER FURTHER INVESTIGATION, THE LOT NUMBER IS UNKNOWN FOR THE 2.4MM X 20MM TIGER CANNULATED SCREW DUE TO THE LIMITED NATURE OF THE COMPLAINT. IT IS DOCUMENTED THAT THE 2.4MM X 20MM TIGER CANNULATED SCREW WAS IMPLANTED A FEW MONTHS PRIOR IN AN ENTIRELY DIFFERENT STATE. THE IMPLANTATION DATE AND LOCATION ARE UNKNOWN. THUS, ANY POTENTIAL LOT NUMBERS FOR THE REMOVED 2.4MM X 20MM TIGER CANNULATED SCREW CANNOT BE DETERMINED. IT IS NOTABLE THAT THE SCREW SIZE IS POTENTIALLY FROM ANOTHER DISTRIBUTOR'S WAREHOUSE. AS A RESULT OF THE LIMITED INFORMATION AVAILABLE REGARDING THE IMPLANTATION PROCEDURE, POTENTIAL LOT NUMBERS COULD NOT BE IDENTIFIED AND DHR REVIEW CANNOT BE CONDUCTED.
ON 11/27/2019, AN R.LPN EMAILED [email protected] THE FOLLOWING: "HELLO, DOCTOR 1 IS A PODIATRIST AT FACILITY X. HE IS IN NEED OF A SCREWDRIVER FOR A SURGICAL HARDWARE REMOVAL CASE IN FACILITY Y. HERE IS THE INFORMATION ON THE SCREW: IMP SCR TRILLIANT CAN TIGER 2.4X20MM TI - IMPLANTED (LEFT) TOE . INVENTORY ITEM: IMP SCR TRILLIANT CAN TIGER 2.4X20MM TI 200-24-020 . MODEL/CAT NUMBER: 200-24-020 MANUFACTURER: TRILLIANT SURGICAL. PLEASE LET US KNOW HOW WE CAN OBTAIN THIS SCREWDRIVER. DOCTOR 1 CAN BE REACHED AT [PHONE NUMBER] FOR ANY FOLLOW UP QUESTIONS. THANKS MUCH! X R.LPN". A TRILLIANT SURGICAL SALES SUPPORT SPECIALIST FOLLOWED UP ON 11/27/2019 VIA PHONE CALL AND ASKED FOR FURTHER DETAILS REGARDING THE REMOVAL. DOCTOR 1 STATED THAT THE REMOVAL WILL BE HAPPENING ON (B)(6) 2019 AT 3:30PM AT FACILITY Y (NOT A CURRENT TRILLIANT SURGICAL CUSTOMER AS OF (B)(6) 2019). DOCTOR 1 REPORTED THAT THE 37-YEAR-OLD FEMALE PATIENT STATED THAT SHE ORIGINALLY HAD THE 2.4MM X 20MM TIGER CANNULATED SCREW (200-24-020) IMPLANTED A "FEW MONTHS PRIOR IN [A DIFFERENT STATE]". DOCTOR 1 STATED THAT THE PATIENT CAME IN REPORTING THAT THE SCREW HAD BECOME SUPERFICIALLY VISIBLE AS THE SWELLING AT THE SURGICAL SITE HAD BEGUN TO SUBSIDE. THE PROTRUDING SCREW WAS REPORTED TO BE "AFFECTING THE INNER SPACE / PORTION OF THE FOOT", HOWEVER, NO REPORTED PAIN WAS NOTED. DOCTOR 1 REQUESTED THE 2.0/2.4MM CANNULATED SCREW DRIVER BIT (210-24-003) TO HELP ASSIST IN THE REMOVAL AND TRILLIANT SURGICAL'S LOCAL SALES REPRESENTATIVE WILL PROVIDE HIS OWN 210-24-003 FOR THE REMOVAL CASE. PARTS WERE NOT RETURNED TO CORPORATE FOR REVIEW.
EVENT DESCRIPTION: A 200-24-020 TIGER CANNULATED SCREW WAS REMOVED DUE TO THE IMPLANT BEING REPORTED AS EXPOSED THROUGH THE SURGICAL SITE. THE PATIENT WAS NOT REPORTING PAIN. REVIEW OF SURGICAL TECHNIQUE: NO INFORMATION WAS PROVIDED ABOUT THE ORIGINAL IMPLANTATION OF THE SCREW. THE CUSTOMER COMPLAINTS LOG, FRM (B)(4) WAS REVIEWED AND DID NOT IDENTIFY ANY OTHER COMPLAINTS ASSOCIATED WITH THIS SALES REPRESENTATIVE. DHR REVIEW: THE SCREW LOT NUMBER WAS NOT ABLE TO BE DEFINITELY DETERMINED, AS THE EXACT DATE AND LOCATION OF IMPLANTATION IS UNKNOWN. THE NETSUITE ERP SYSTEM WAS UTILIZED TO DETERMINE POTENTIAL SCREW LOTS WHICH WERE PRESENT NEAR 6 DURING THE RELEVANT TIME PERIOD WHICH COULD HAVE BEEN THE POTENTIAL SCREW. A TOTAL OF 9 POTENTIAL LOTS WERE IDENTIFIED, THESE 9 DHR'S WERE REVIEWED FOR ANY RELEVANT NCR'S, DEVIATIONS, OR REWORKS, AND WERE VERIFIED THAT THE TRAVELER WAS COMPLETE. NO ISSUES RELATED TO THE EVENT WERE IDENTIFIED IN ANY DHR. RELEVANT DHR'S: (B)(4). VISUAL / DIMENSIONAL INSPECTION: THE SCREW WAS NOT RETURNED TO CORPORATE FOR EVALUATION AND A VISUAL/DIMENSIONAL INSPECTION CANNOT BE COMPLETED. SIMULATED USE TESTING: THE SCREW WAS NOT RETURNED TO CORPORATE FOR EVALUATION AND, ADDITIONALLY, DUE TO THE NATURE OF THE COMPLAINT, SIMULATED USE TESTING CANNOT BE COMPLETED. EVALUATION OF SIMILAR COMPLAINTS: FRM (B)(4), CUSTOMER COMPLAINT REPORT LOG, WAS REVIEWED FOR THE PAST 12 MONTHS TO DETERMINE ANY RELEVANT EVENTS. 3 TOTAL COMPLAINTS WERE IDENTIFIED. (B)(4) REPORTED THAT A 200-24-018 TIGER SCREW WAS REMOVED DUE TO AN INFECTION AND WAS UNABLE TO ISOLATE A ROOT CAUSE. (B)(4) REPORTED THAT A TIGER SCREW WAS REMOVED TO PATIENT PAIN AND WAS NOT ABLE TO ISOLATE A ROOT CAUSE. (B)(4) REPORTED THAT A 200-2X-0XX TIGER SCREW WAS REMOVED DUE TO PATIENT PAIN AND WAS NOT ABLE TO ISOLATE A ROOT CAUSE. THIS IS THE FIRST IDENTIFIED EVENT INVOLVING DEVICE MIGRATION AND THAT DID NOT INVOLVE PATIENT PAIN. SUMMARY / ROOT CAUSE ANALYSIS: DUE TO THE PART NOT BEING RETURNED AND LIMITED INFORMATION BEING AVAILABLE, A ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. THE FIELD SHALL CONTINUE TO BE MONITORED. NOTE: ALL INFORMATION WAS ATTEMPTED TO BE GATHERED THROUGH A GOOD FAITH EFFORT. THE EXACT IMPLANTATION DATE WAS ESTIMATED AS "(B)(6) 2019" AS IT WAS REPORTED TO BE IMPLANTED "A FEW MONTHS PRIOR".
ON 11/27/2019, (B)(6) THE FOLLOWING: "HELLO, DR. (B)(6) IS A PODIATRIST AT (B)(6). HE IS IN NEED OF A SCREWDRIVER FOR A SURGICAL HARDWARE REMOVAL CASE IN (B)(6). HERE IS THE INFORMATION ON THE SCREW: IMP SCR TRILLIANT CAN TIGER 2.4X20MM TI - IMPLANTED (LEFT) TOE. INVENTORY ITEM: IMP SCR TRILLIANT CAN TIGER 2.4X20MM TI 200-24-020. MODEL/CAT NUMBER: 200-24-020 MANUFACTURER: TRILLIANT SURGICAL. PLEASE LET US KNOW HOW WE CAN OBTAIN THIS SCREWDRIVER. DR. (B)(6) CAN BE REACHED AT (B)(6) FOR ANY FOLLOW UP QUESTIONS. THANKS MUCH! (B)(6)". (B)(6), TRILLIANT'S SALES SUPPORT SPECIALIST, FOLLOWED UP ON 11/27/2019 VIA PHONE CALL AND ASKED FOR FURTHER DETAILS REGARDING THE REMOVAL. DR. (B)(6) STATED THAT THE REMOVAL WILL BE HAPPENING ON (B)(6) 2019 AT 3:30PM AT (B)(6) HOSPITAL (NOT A CURRENT TRILLIANT CUSTOMER AS OF (B)(6) 2019.) DR. (B)(6) REPORTED THAT THE (B)(6) YEAR OLD FEMALE PATIENT STATED THAT SHE ORIGINALLY HAD THE 200-24-020 (2.4 X 20MM TIGER CANNULATED SCREW IMPLANTED A "FEW MONTHS PRIOR IN (B)(6)." DR. (B)(6) STATED THAT THE PATIENT CAME IN REPORTING THAT THE SCREW HAD BECOME SUPERFICIALLY VISIBLE AS THE SWELLING AT THE SURGICAL SITE HAD BEGUN TO SUBSIDE. THE PROTRUDING SCREW WAS REPORTED TO BE "AFFECTING THE INNER SPACE / PORTION OF THE FOOT" HOWEVER, NO REPORTED PAIN WAS NOTED. DR. (B)(6) REQUESTED THE 2.0/2.4 TIGER CANNULATED DRIVER BIT TO HELP ASSIST IN THE REMOVAL AND TRILLIANT'S LOCAL REPRESENTATIVE, (B)(6), WILL PROVIDE HIS OWN 210-24-003 (2.0/2.4 TIGER CANNULATED DRIVER BIT) FOR THE REMOVAL CASE. PARTS WERE NOT RETURNED TO CORPORATE FOR REVIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1304543 | 2.4MM X 20MM TIGER CANNULATED SCREW | TIGER CANNULATED SCREW SYSTEM SCREW | HWC | TRILLIANT SURGICAL | 200-24-020 | UNK | 00812926020778 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |