STERNALOCK BLU SYSTEM PLATE, 12 HOLE WIDE LADDER
Report
- Report Number
- 0001032347-2018-00457
- Event Type
- Injury
- Date Received
- August 6, 2018
- Date of Event
- April 10, 2018
- Report Date
- December 20, 2018
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- HRS
- PMA / PMN Number
- PK161896
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
THE LOT NUMBER IS UNKNOWN, HOWEVER A REVIEW OF THE SALES HISTORY IDENTIFIED SEVEN POTENTIAL LOTS; J043550, J247780, J358540, J130000, J498600, J351380, AND J155750. REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. FROM THE PROVIDED X-RAYS IT WAS CLEAR THAT THE PLATE HAD FRACTURED ALONG THE OSTEOTOMY CUT LINE WHERE THE 2 PLATE SCREW HOLES WERE LEFT OPEN, THEREFORE THE COMPLAINT IS CONFIRMED. IT APPEARED AS THOUGH THE SCREWS WERE STILL SECURED IN THEIR ORIGINAL LOCATIONS. THE INITIAL SURGERY TOOK PLACE ON 27 OCT 2017. THE IMPLANT FRACTURED AND A SECOND SURGERY WAS DONE ON 10 APRIL 2018 TO REMOVE THE IMPLANTS AND REPLACE THEM WITH SYNTHES. THE SURGEON STATED DURING A FOLLOW-UP CONVERSATION THAT HE DOESN¿T KNOW IF THE PATIENT AND HER FAMILY HAVE BEEN FOLLOWING ALL THE POST-OPERATIVE RULES LIKE NO SPORTS FOR 3 MONTHS. THE PLATE WAS USED FOR THE TREATMENT OF THE CURRARINO-SILVERMAN-SYNDROME, WHERE HE REMOVED A PART OF THE STERNUM TO BRING IT IN AN UPRIGHT POSITION. FROM THE PROVIDED DOCUMENTS IT CAN BE SEEN THAT THERE IS A POSSIBLE GAP BETWEEN THE TWO HALVES OF THE STERNUM. THE INSTRUCTIONS FOR USE (IFU) STATES IN THE SECTION TITLED WARNINGS: ADEQUATELY INSTRUCT THE PATIENT. POSTOPERATIVE CARE IS IMPORTANT. THE PATIENT¿S ABILITY AND WILLINGNESS TO FOLLOW INSTRUCTION IS ONE OF THE MOST IMPORTANT ASPECTS OF SUCCESSFUL MANAGEMENT OF FRACTURE OR OTHER NON-UNION. PATIENTS WITH SENILITY, MENTAL ILLNESS, ALCOHOLISM, OR DRUG ABUSE MAY BE AT HIGHER RISK OF DEVICE FAILURE SINCE THESE PATIENTS MAY IGNORE INSTRUCTIONS AND ACTIVITY RESTRICTIONS. THE PATIENT IS TO BE INSTRUCTED IN THE USE OF EXTERNAL SUPPORTS AND BRACES THAT ARE INTENDED TO IMMOBILIZE THE SITE OF THE FRACTURE OR OTHER NON-UNION AND LIMIT LOAD BEARING. THE PATIENT IS TO BE MADE FULLY AWARE AND WARNED THAT THE DEVICE DOES NOT REPLACE NORMAL HEALTHY BONE, AND THAT THE DEVICE CAN BREAK, BEND OR BE DAMAGED AS A RESULT OF STRESS, ACTIVITY, LOAD BEARING OR INADEQUATE BONE HEALING. THE PATIENT IS TO BE MADE AWARE AND WARNED OF GENERAL SURGICAL RISKS, COMPLICATIONS, POSSIBLE ADVERSE EFFECTS, AND TO FOLLOW THE INSTRUCTIONS OF THE TREATING PHYSICIAN. THE PATIENT IS TO BE ADVISED OF THE NEED FOR REGULAR POSTOPERATIVE FOLLOW-UP EXAMINATION AS LONG AS THE DEVICE REMAINS IMPLANTED. THE IFU ALSO STATES IN THE SECTION TITLED BONE PLATES: CARE MUST BE TAKEN TO ACHIEVE THE APPROPRIATE CONTOUR WITH AS FEW BENDS AS POSSIBLE. REPEATED BENDING OF TITANIUM INCREASES THE RISK OF FRACTURE. SHARP ANGLES AND SMALL BENDING RADII MUST BE AVOIDED TO REDUCE THE RISK OF DEVICE BREAKAGE. DEVICE HISTORY RECORDS (DHR'S) WERE REVIEWED FOR THE POTENTIAL LOTS AND NO DISCREPANCIES WERE FOUND. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO MOVEMENT OF THE CHEST WALL LIKELY FATIGUED THE PLATE AND CAUSED FRACTURE AT THE WEAKEST POINT. 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.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT IS REPORTED THE DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT IS AGAINST HOSPITAL POLICY. UNIQUE IDENTIFIER (UDI) # (B)(4). MEDICAL PRODUCT: BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW, 2.4MM CANCELLOUS SELF-DRILLING LOCKING SCREWS CATALOG #: NI LOT #: NI, QTY. 8; BIOMET MICROFIXATION STERNALOCK BLU SYSTEM SCREW 2.7MM CANCELLOUS LOCKING SCREWS CATALOG #: NI LOT #: NI, QTY. 2. THERAPY DATE: (B)(6) 2018.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.
ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED ONE (1) PLATE AND TEN (10) SCREWS WERE EXPLANTED AND REPLACED WITH A PLATE FROM A DIFFERENT MANUFACTURER. THE SURGEON INDICATED HE DID NOT KNOW IF THE PATIENT WAS COMPLIANT WITH POST-OPERATIVE INSTRUCTIONS. THE ORIGINAL PROCEDURE WAS TO TREAT CURRARINO-SILVERMAN-SYNDROME, IN WHICH THE SURGEON REMOVED A PART OF THE STERNUM TO BRING IT IN AN UPRIGHT POSITION.
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED A "STERNALOCK PLATE BROKE (PRESUMABLY BROAD CIRCUIT BOARD) IN A JUVENILE PATIENT." ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 594650 | STERNALOCK BLU SYSTEM PLATE, 12 HOLE WIDE LADDER | BONE PLATE | HRS | BIOMET MICROFIXATION | N/A | SEE H10 NARRATIVE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |