D
Patient 1
THE WIRE FIXATION NUT WILL NOT SCREW ONTO OFFSET WIRE FIXATION BOLT.
MAUDE MDR 2380074
- MDR report key
- 2380074
- Report number
- 1818910-2011-25226
- Event key
- 0
- Event type
- 3
- Date received
- 2011-12-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- KATHERINE SEPPA
- Address
- 700 ORTHOPAEDIC DRIVE WARSAW IN 46581 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | WIRE FX BOLT SLOTTED SS | TRAUMA FIXATION | DEPUY LELOCLE | HXK | 818050006 | 582520 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-12-16 | 0 |
Event Narratives#
N
Patient 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
N
Patient 1
EXAMINATION OF THE RETURNED PRODUCTS CONFIRMED THE COMPLAINT. THE CAUSE IS ATTRIBUTED TO THE SUPPLIERS MANUFACTURING PROCESS, THE MAJOR DIAMETER OF THE BOLT THREADS IS OVERSIZED UP TO .004, PREVENTING THE NUT FROM FASTENING TO THE BOLT. THE THREAD FORM IS SHARP AT THE CREST, COMPARED TO CONFORMING BOLTS. HOLD ORDER (B)(4) WAS INITIATED ON (B)(4) 2011. AN HHE WAS CONDUCTED AND IS DOCUMENTED ON (B)(4), (B)(4). THE LOT NUMBERS AFFECTED WERE RECALLED, ROOT CAUSES AND CORRECTIVE ACTIONS ARE CAPTURED IN (B)(4) THAT WAS INITIATED ON (B)(4) 2011. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.
N
Patient 1
THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED HEAD PART AND LOT CODE COMBINATION; TWO PRIOR REPORTS FOR THE METAL INSERT PART AND LOT CODE COMBINATION. HOWEVER, REVIEW OF THE AS400 SYSTEM SHOW THAT 14 OTHER DEVICES FROM THE REPORTED METAL INSERT LOT HAVE BEEN DELIVERED AND/OR INVOICED AND CAN BE REASONABLY CONCLUDED IMPLANTED WITHOUT ISSUE. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO RELATED MANUFACTURING DEVIATIONS OR RELATED ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.