| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TMAX SHOULDER TABLE | TABLE AND ATTACHMENTS, OPERATING-ROOM | SMITH & NEPHEW, INC. | BWN | TBD | 7210551 | UNKNOWN | R | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-12-01 | 0 |
Patient 1
THE DEVICE HAS NOT BEEN RETURNED. DUE TO THE DEVICE NOT BEING RETURNED, WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE USER TO EXPERIENCE THE REPORTED INCIDENT. IN THE EVENT THE SAMPLE IS RETURNED FOR EVALUATION THE COMPLAINT WILL BE REOPENED FOR ADDITIONAL INVESTIGATION. NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME. (B)(4).
Patient 1
REPORTEDLY, THE GOLD BALL THAT IS CONNECTED TO THE METAL ROD WHICH CONTROLS THE HEAD HEIGHT ON THE TMAX SHOULDER TABLE CAME LOOSE DURING SURGERY. THE HEAD WAS UNSTABLE DURING THE PROCEDURE AND THE SURGEON OR ANAESTHETIST HAD TO HOLD THE HEAD SECURE DURING THE OPERATION. IT IS REPORTED THAT THE PATIENT'S HEAD WAS NOT IN THE CORRECT POSITION DURING THE PROCEDURE AND THIS COULD HAVE CAUSED AN INJURY.
Patient 1
ONE CUSTOMER HEADSET POSITIONING SYSTEM WAS RECEIVED ON 12/23/2015 AND CONFIRMED TO BE SERIAL NUMBER (B)(4). THE COMPLAINT REPORTED THAT THE DEVICE BECAME LOOSE AND INADVERTENTLY CAUSED INSTABILITY OF THE PATIENT?S HEAD DURING A SURGERY.UPON VISUAL INSPECTION, NO DAMAGES TO THE UNIT WERE FOUND. THE UNIT WAS FUNCTIONALLY TESTED WITH THE 30-LB SLIP TEST PER PROCEDURE AND THE UNIT WAS ABLE TO PERFORM AS EXPECTED. UPON CLOSER EXAMINATION, IT WAS DETERMINED THAT THE THREAD LOCKER USED TO MATE, LOCK, AND SEAL THE BALL & SOCKET SUBASSEMBLY ((B)(4)) TO THE SLIDE HEX BAR (B)(4) HAD FAILED. THE INVESTIGATION CONCLUDES THAT IT IS POSSIBLE THAT AN INADEQUATE AMOUNT OF THREAD LOCKER WAS APPLIED INTO THE BALL & SOCKET SUBASSEMBLY WHEN ASSEMBLING DUE TO OPERATOR ERROR DURING THE MANUFACTURING PROCESS. THIS ISSUE WAS PREVIOUSLY ADDRESSED WITH DEFECT AWARENESS TRAINING. THE ASSEMBLY PROCEDURE WAS ALSO UPDATED TO REFLECT PROPER APPLICATION AND AMOUNT TO USE. THE ACTUAL DATE OF MANUFACTURE IS UNKNOWN, BUT THIS UNIT WAS MANUFACTURED BY TENET MEDICAL PRIOR TO THE SMITH & NEPHEW ACQUISITION. THEREFORE, IT WAS MANUFACTURED PRIOR TO THE AWARENESS TRAINING. THE UNIT WILL BE SENT TO SERVICE FOR REPAIRS. NO FURTHER INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4).