ST PRE-BENT PLATE 12-HOLE
Report
- Report Number
- 0001032347-2024-00222
- Event Type
- Injury
- Date Received
- July 15, 2024
- Date of Event
- July 10, 2024
- Report Date
- December 31, 2024
- Manufacturer
- BIOMET MICROFIXATION
- Product Code
- HRS
- UDI-DI
- 00841036280741
- PMA / PMN Number
- K142823
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS: ITEM# UNK, LOT# UNK; UNKNOWN SCREW. G2: FOREIGN SOURCE: UNITED KINGDOM. CONSUMER: PATIENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS A1, A2, A3, B2, B3, B4, B5, D6B, G3, G6, H2, H6, H10, AND H11. CORRECTION IS IN D6A.
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10 ¿ MEDICAL PRODUCTS: QUANTITY OF 4 FROM PART AND LOT COMBINATION BELOW: ITEM 76-2412ST, LOT #155902; 6PK SCREW, SELF DRILL, X-DRV, LOCKING, 6-PK, ITEM 76-2410ST, LOT #230590; 6PK SCREW, SELF DRILL, X-DRV, LOCKING, 6-PK. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: CT REPORT DETERMINED NON-UNION OF LEFT LATERAL 8TH RIB FRACTURE. LATER RECORD INDICATED, PATIENT REFRACTURED AT THE SAME SITE OF NON-UNION AND WAS FIXED WITH PLATE AND 4 SCREWS ON EACH SIDE WITH NO INTRA-OPERATIVE COMPLICATIONS/EVENTS. IT WAS REPORTED THE PATIENT ROLLED OVER IN BED AND THE PLATE SUDDENLY SNAPPED, CAUSING EXCRUCIATING PAIN. X-RAYS SHOWED THE PLATE HAD FRACTURED WITH SCREWS PULLED OUT ON A SINGLE SIDE OF THE PLATE. DEVICES EXPLANTED, WITH NO COMPLICATIONS. PLATE WAS FRACTURED IN THE MIDDLE THROUGH THE SCREW HOLE. THE RIB WAS DETERMINED TO BE HEALED, SO THE DECISION WAS MADE TO NOT IMPLANT A NEW PLATE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED, BASED ON MEDICAL RECORDS. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B3, B4, B5, D4, G3, G6, H2, H10, AND H11. CORRECTIONS ARE IN SECTION D6.
IT IS REPORTED THAT THE PATIENT HAS CONTACTED THE SURGEON TO SAY THAT HE FELT PAIN IN HIS RIB AND WENT FOR X-RAYS. THE X-RAY SHOWS A FRACTURED PLATE WITH SCREWS PULLED OUT ON SINGLE SIDE OF THE PLATE. SURGEON IS SCHEDULED TO SEE THE PATIENT TO SCHEDULE A CT SCAN FOR INSPECTION. A REVISION WILL BE NEEDED; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. THE EVENT OCCURRED 4 MONTHS AFTER SURGERY.
IT IS REPORTED THAT THE PATIENT HAS CONTACTED THE SURGEON TO SAY THAT HE FELT PAIN IN HIS RIB AND WENT FOR X-RAYS. THE X-RAY SHOWS A FRACTURED PLATE WITH SCREWS PULLED OUT ON SINGLE SIDE OF THE PLATE. SURGEON IS SCHEDULED TO SEE THE PATIENT TO SCHEDULE A CT SCAN FOR INSPECTION. A REVISION WILL BE NEEDED; HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. THE EVENT OCCURRED 4 MONTHS AFTER SURGERY. IT IS FURTHER REPORTED BY THE PATIENT THAT THERE WAS NO FALL OR TRAUMA PRIOR TO THE PLATE FRACTURE. PATIENT INDICATED THAT THEY ROLLED OVER IN BED AND PLATE SUDDENLY SNAPPED AND CAUSE EXCRUCIATING PAIN. THE PATIENT HAS BEEN REVISED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED A PATIENT HAD AN INITIAL 8TH RIB FIXATION DUE TO PAIN AND MALUNION OF A FRACTURE THAT OCCURRED 3 YEARS PRIOR AFTER SNEEZING. SUBSEQUENTLY, APPROXIMATELY FOUR MONTHS POST OP, ROLLED OVER IN BED AND EXPERIENCED SUDDEN PAIN AND RADIOGRAPHIC IMAGING DISPLAYED THAT SCREWS PULLED OUT ON ONE SIDE OF THE PLATE AND THE PLATE HAD FRACTURED. ON A LATER DATE, THE PATIENT UNDERWENT A SECOND OPERATION WHERE THE PLATE AS FOUND BROKE IN THE MIDDLE THROUGH THE SCREW HOLD. ALL PRODUCTS WERE REMOVED AS THE FRACTURE WAS FOUND HEALED AND STABLE AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286928 | ST PRE-BENT PLATE 12-HOLE | PLATE, FIXATION, BONE | HRS | BIOMET MICROFIXATION | N/A | 180669 | 00841036280741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| H| O | SEE H11 |