BONE SCREW CORTICAL 44MM
Report
- Report Number
- 0001825034-2017-03530
- Event Type
- Injury
- Date Received
- June 1, 2017
- Date of Event
- May 19, 2016
- Report Date
- March 8, 2018
- Manufacturer
- BIOMET TRAUMA
- Product Code
- HSB
- PMA / PMN Number
- PK871539
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE COULD NOT BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-03502, 0001825034-2017-03531, 0001825034-2017-03532, 0001825034-2017-03533. MEDICAL PRODUCTS-TIBIAL NAIL CATALOG#:181209315 LOT#:DNLCTG, BONE SCREW CATALOG#:1402236 LOT#: UNK, SCREW CATALOG#:151550 LOT#:UNK, SCREW CATALOG#:151560 LOT#:UNK, THREADED GUIDE PIN CATALOG#:903003004 LOT#:UNK, DRILL BIT CATALOG#:281012138 LOT#:UNK, DRILL BIT CATALOG#:281012144 LOT#: UNK, BALL NOSE GUIDE WIRE CATALOG#:281001080 LOT#:862670, BALL NOSE GUIDE WIRE CATALOG#:281001100 LOT#:661670.
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.
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.
IT IS REPORTED THAT THE PATIENT INITIALLY UNDERWENT A TIBIAL FRACTURE FIXATION TRAUMA NAIL PROCEDURE. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING PAIN AND A RASH BEGINNING A FEW MONTHS POST-IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE.
IT IS REPORTED THAT THE PATIENT INITIALLY UNDERWENT A TIBIAL FRACTURE FIXATION TRAUMA NAIL PROCEDURE. SUBSEQUENTLY, THE PATIENT'S SCREWS WERE REMOVED APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION DUE TO EXPERIENCING PAIN LEADING TO AMBULATION DIFFICULTIES AND A RASH BEGINNING A FEW MONTHS POST-IMPLANTATION. OPERATIVE NOTES RECEIVED REPORT THE PATIENT HAD COMPLAINTS OF PAIN RELATED TO PROMINENT PROXIMAL AND DISTAL LOCKING SCREWS. THE SCREWS WERE REMOVED AND NOTED TO BE INTACT. X-RAY REVIEW SHOWS THAT SCREWS BACKED OUT.
IT IS REPORTED THAT THE PATIENT INITIALLY UNDERWENT A TIBIAL FRACTURE FIXATION TRAUMA NAIL PROCEDURE. SUBSEQUENTLY, THE PATIENT'S SCREWS WERE REMOVED APPROXIMATELY ONE (1) YEAR POST-IMPLANTATION DUE TO EXPERIENCING PAIN LEADING TO AMBULATION DIFFICULTIES AND A RASH BEGINNING A FEW MONTHS POST-IMPLANTATION. OPERATIVE NOTES RECEIVED REPORT THE PATIENT HAD COMPLAINTS OF PAIN RELATED TO PROMINENT PROXIMAL AND DISTAL LOCKING SCREWS. THE SCREWS WERE REMOVED AND NOTED TO BE INTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386890 | BONE SCREW CORTICAL 44MM | ROD, FIXATION | HSB | BIOMET TRAUMA | N/A | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Hospitalization| O| R |