1.0MM CABLE WITH CRIMP 750MM-STERILE
Report
- Report Number
- 2520274-2016-12951
- Event Type
- Injury
- Date Received
- May 31, 2016
- Report Date
- May 16, 2016
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- JDQ
- PMA / PMN Number
- PK992616
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INITIALS ARE (B)(6). PATIENT WEIGHT IS NOT AVAILABLE FOR REPORTING. DATE OF EVENT: UNKNOWN. (B)(4). THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. THIS DEVICE IS STILL IMPLANTED IN THE PATIENT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. DHR REVIEW FOR PART# PART NO. 298.800.01S LOT # P061844, RELEASE TO WAREHOUSE DATE: 17 DEC 2009, EXPIRATION DATE: 31 OCT 2018, SUPPLIER: (B)(4). NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A SERVICE AND REPAIR EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: SYNTHES MANUFACTURING LOCATION WAS DISCOVERED UPON DHR FINDINGS. (B)(4). DEVICE 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.
RELEVANT TEST/LABORATORY DATA: ULTRA SONOGRAM, CT SCAN. PAST SURGICAL HISTORY, COMORBIDITIES AND RACE UPDATED. (B)(4). CONCOMITANT MEDICAL PRODUCTS: 4.5MM CANNULATED SCREW PARTIALLY THREADED / 42MM (PART# 214.542, LOT# UNKNOWN, QUANTITY 1); 1.6MM NON-THREADED GUIDE WIRE SPADE POINT ON ONE END 150MM (PART# 292.727, LOT# UNKNOWN, QUANTITY 2). DEVICE 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.
PRODUCT WAS NOT RETURNED; THE DEVICE HISTORY RECORDS REVEALED NO NCR'S WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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.
IT IS REPORTED THAT THE 1.0MM CABLE WITH CRIMP WAS DISCOVERED TO HAVE BROKEN POSTOPERATIVELY. THE PATIENT INITIALLY IMPLANTED WITH THE 1.0MM CABLE AND AN UNKNOWN QUANTITY OF UNKNOWN 4.5MM CANNULATED SCREWS TO TREAT A PATELLA FRACTURE ON (B)(6) 2015. DURING A FOLLOW UP VISIT WITH THE SURGEON ON (B)(6) 2016, AN UNKNOWN NUMBER OF X-RAYS WERE TAKEN WHICH SHOWED THE CABLE HAD BROKEN IN TWO, APPROXIMATELY IN THE MIDDLE OF THE CABLE. THE FRACTURE HAD HEALED SUCCESSFULLY. THE PATIENT WAS GIVEN THE OPTION TO UNDERGO REVISION SURGERY TO REMOVE THE CABLE, BUT THE PATIENT HAS NOT RESPONDED WITH A DECISION AS OF THE DATE OF THIS REPORT. AT THIS TIME, THERE IS NO PLAN TO PERFORM REVISION SURGERY. THIS REPORT IS 1 OF 1 FOR (B)(4).
UPDATE 16AUG2016: PHONE CALL RECEIVED FROM ADVOCATE OF PATIENT ON 16AUG2016 AND PROVIDED ADDITIONAL INFORMATION. IT WAS REPORTED, THE PATIENT IS IN EXCRUCIATING PAIN AND REQUIRES REVISION SURGERY, HOWEVER, THE PATIENT DOES NOT HAVE INSURANCE TO COVER THE PROCEDURE.
MEDICAL RECORDS RECEIVED ON SEP 06, 2016; IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM AS SHE HIT A STEP WRONG AND TWISTED HER KNEE. PATIENT WAS NOT AMBULATORY STATUS POST INCIDENT AND HAS NO PRIOR KNEE INJURIES. REPORTEDLY, PAIN IS A TEN (10) OUT OF TEN (10) ALONG WITH BRUISING. PATIENT EXPERIENCE GAIT PROBLEM, BRUISING, LEFT KNEE PAIN, AND JOINT SWELLING PRIOR TO SURGERY. THE PATIENT UNDERWENT SURGERY FOR HER PATELLA. OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LET PATELLA. PATIENT TOLERATED THE PROCEDURE WELL. POSTOPERATIVELY, THE PATIENT WAS EXPERIENCING AN INCREASE IN PAIN AND SWELLING; AN ULTRASONOGRAM WAS ORDERED AND DISCOVERED AN ACTURE VENOUS EMBOLISM AND THROMBOSIS OF DEEP VESSELS (DVT) OF DISTAL LOWER EXTREMITY. MEDICINE WAS CONSULTED AND HAVE BEEN MANAGING HER DVT. PATIENT ALSO HAD A HEADACHE, RULED OUT CONCERN FOR HEMORRHAGE WITH COMPUTERIZED TOMOGRAPHY (CT) SCAN AS PATIENT WAS RECENTLY PLACED ON ANTICOAGULATION. SHE WAS THEN CLEARED BY MEDICINE AND READY FOR DISCHARGE. PATIENT WILL UNDERGO PHYSICAL THERAPY.
UPDATE: 20DEC2016: MEDICAL RECORDS RECEIVED; FOUR (4) CLINIC VISITS WITH XRAYS RESULTS FROM (B)(6) 2015 SHOWED STEADY IMPROVEMENT, GOOD HEALING AND POSITIONING OF THE PATELLA. A CLINIC VISIT (B)(6) 2016, THE PATIENT STATED SHE WAS GETTING ALONG PRETTY WELL WITH HER KNEE. ABLE TO WALK AND DO NORMAL ACTIVITIES; GET DOWN ON HER KNEE SOME WHILE CLEANING AROUND THE HOUSE. SHE REPORTED A POP IN HER LEFT KNEE WITH SOME PAIN AND WAS SEEN A COUPLE OF DAYS AFTERWARD BY THE PHYSICAL THERAPIST. XRAYS WERE TAKEN ON THIS CLINIC VISIT SHOWED THE CABLE THAT WAS USED IN A FIGURE EIGHT FASHION HAD BROKEN. THE REST OF THE HARDWARE APPEARS TO BE IN SATISFACTORY POSITION AND GOOD ALIGNMENT. IT DOES APPEAR THE FRACTURE HAD HEALED. THE PATIENT'S RANGE OF MOTION FROM ZERO TO BETTER THAN 125 DEGREE OF FLEXION. VARUS VAGUS STRESS APPEARS TO BE GROSSLY INTACT. NO ECCHYMOSIS AROUND THE KNEE. A BIT OF SWELLING NOTED OVER THE MEDIAL ASPECT, BUT DOES NOT SEEM TO BE VERY PAINFUL TO PALPITATION. NEUROVASCULAR STATUS IS GROSSLY INTACT. NO SIGNS OF DVT. OPTIONS WERE DISCUSSED TO REMOVE OR LEAVE HARDWARE IN PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344642 | 1.0MM CABLE WITH CRIMP 750MM-STERILE | CERCLAGE FIXATION | JDQ | SYNTHES MONUMENT | P061844 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |