3.5MM TI LOCKING SCREW SELF-TAPPING 24MM
Report
- Report Number
- 8030965-2018-55128
- Event Type
- Injury
- Date Received
- July 17, 2018
- Report Date
- June 26, 2018
- Manufacturer
- OBERDORF SYNTHES PRODUKTIONS GMBH
- Product Code
- KTT
- UDI-DI
- 07611819239241
- PMA / PMN Number
- K000684
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. CORRECTED DATA: UPDATED CONCOMITANT DEVICES TO CORRECT THE QUANTITY OF PART 413.030, LOT L115506. 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.
A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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.
DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 413.024, LOT# L299658. MANUFACTURING LOCATION: BETTLACH, RELEASE TO WAREHOUSE DATE: FEB 15, 2017. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. THE RAW MATERIAL CERTIFICATE WAS REVIEWED, AND THE USED MATERIAL WAS ACCORDING TO SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. AS RECEIVED CONDITION, THREE SCREWS AND ONE PLATE HAVE BEEN RETURNED UNPACKED AND OUTSIDE THE ORIGINAL SYNTHES BAG. ALL THREE SCREWS WERE BROKEN AT THE NECK POINT AND HAVE STRONG TRACES OF USE ON ITS SURFACE AND ALONG OF THE THREAD PART OF THE SHAFT. THIS TYPE OF SCREW IS LASER-MARKED DURING THE MANUFACTURING PROCESS, THE ARTICLE PART AND THE LOT NUMBER ON THE SCREW MATCH THOSE OF THE PACKAGING AND THE LABEL. AS RECEIVED, ONE HEAD (PART# 413.024, LOT# L299658) WAS SCREWED IN IN THE PLATE. THIS HEAD WAS REMOVED FROM THE PLATE TO BE MEASURED. ALL DIMENSIONS OF THE BROKEN SCREWS RELEVANT TO THE COMPLAINT CONDITION WERE MEASURED AND HAVE FULFILLED THEIR SPECIFICATIONS ACCORDING TO THE DRAWING. BESIDES, DURING THE MANUFACTURING PROCESS ALL THE RELEVANT FEATURES WERE INSPECTED AND DOCUMENTED ACCORDING TO THE INSPECTIONS SHEET. THEREFORE, THIS SCREW WAS MANUFACTURED ACCORDING TO ITS QUALITY STANDARDS AND A MANUFACTURING ISSUE CAN BE EXCLUDED. THE MATERIAL CERTIFICATE REGARDING TO THE LOT L299658 WAS REQUESTED FROM SFS SINCE THE BLANKS ARE RECEIVED FROM THAT COMPANY. THE MATERIAL CERTIFICATE WAS RECEIVED AND REVIEWED. IT FULFILLS ALL SPECIFICATIONS. THE RECEIVED CONDITION OF THE COMPLAINT AGREES WITH THE COMPLAINT DESCRIPTION SINCE THE SCREWS ARE BROKEN AS CLAIMED BY THE CUSTOMER. HOWEVER, FROM THE MANUFACTURING POINT OF VIEW THIS COMPLAINT IS RATED AS NOT VALID SINCE THERE WAS NO MANUFACTURING ISSUE IDENTIFIED DURING THIS INVESTIGATION. DUE TO NO MANUFACTURING ISSUE WAS DETECTED, THEREFORE, NO FURTHER ACTIONS HAVE BEEN TAKEN. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.
CONCOMITANT DEVICES REPORTED: 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART 413.030, LOT L115506, QUANTITY 2). 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART 413.030, LOT L207879, QUANTITY 1). 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART 413.038, LOT L275096, QUANTITY 1). 3.5MM TI CORTEX SCREW 24MM (PART 404.024, LOT 9844343, QUANTITY 1). 3.5MM TI CORTEX SCREW 26MM (PART 404.026, LOT 9909005, QUANTITY 1). 3.5MM TI CORTEX SCREW 28MM (PART 404.028, LOT 9134808, QUANTITY 1). 3.5MM TI LCP® PLATE 12 HOLES 163MM (PART 423.621, LOT 9778619, QUANTITY 1).
CONCOMITANT MEDICAL PRODUCTS: 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART 413.030, LOT L115506, QUANTITY 3), 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART 413.030, LOT L207879, QUANTITY 1), 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART 413.038, LOT L275096, QUANTITY 1), 3.5MM TI CORTEX SCREW 24MM (PART 404.024, LOT 9844343, QUANTITY 1), 3.5MM TI CORTEX SCREW 26MM (PART 404.026, LOT 9909005, QUANTITY 1), 3.5MM TI CORTEX SCREW 28MM (PART 404.028, LOT 9134808, QUANTITY 1), 3.5MM TI LCP® PLATE 12 HOLES 163MM (PART 423.621, LOT 9778619, QUANTITY 1).
IT IS UNKNOWN IF THE REVISION SURGERY WAS COMPLETED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. PATIENT CODE (B)(4) USED TO CAPTURE ADDITIONAL MEDICAL/SURGICAL INTERVENTION REQUIRED. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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 REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT REVISION SURGERY DUE TO AFTER POST-OPERATIVE BREAKAGE OF SCREWS. DURING THE REVISION, THEY KEPT THE PLATE IN PLACE AND REMOVED THE BROKEN SCREWS. PATIENT WAS IMPLANTED WITH NEW SCREWS. POST-OPERATIVE OF THIS REVISION SURGERY, ON AN UNKNOWN DATE, THREE SCREWS BROKE. NEW REVISION SURGERY WILL BE PERFORMED. PATIENT OUTCOME WAS NOT REPORTED. FIRST REVISION SURGERY FROM (B)(6) 2018 IS CAPTURED UNDER (B)(6). THIS PC CAPTURES THE BREAKAGE OF THREE SCREWS POST REVISION SURGERY. CONCOMITANT DEVICES REPORTED: PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); 3.5MM TI LOCKING SCREW SELF-TAPPING 24MM (PART# 413.024, LOT# UNKNOWN, QUANTITY 1); 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART# 413.030, LOT# UNKNOWN, QUANTITY 3); 3.5MM TI LOCKING SCREW SELF-TAPPING 30MM (PART# 413.038, LOT# UNKNOWN, QUANTITY 1); 3.5MM TI CORTEX SCREW SELF-TAPPING 26MM (PART# 404.826, LOT# UNKNOWN, QUANTITY 1); 3.5MM TI CORTEX SCREW SELF-TAPPING 28MM (PART# 404.828, LOT# UNKNOWN, QUANTITY 2). THIS REPORT IS FOR ONE (1) 3.5MM TI LOCKING SCREW SELF-TAPPING 24MM. THIS IS REPORT 1 OF 3 FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 538258 | 3.5MM TI LOCKING SCREW SELF-TAPPING 24MM | APPLIANCE,FIXATION,NAIL | KTT | OBERDORF SYNTHES PRODUKTIONS GMBH | L299658 | 07611819239241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |