| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DOUBLEAIRHOSE L5M F/SYST SYNTHES | INSTRUMENT SURGICAL, ORTHO, PNEUMATIC, POWERED AND ACCESSORY/ATTACHMENT | DEPUY SYNTHES PRODUCTS LLC | HSZ | 519.530 | N/I | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-12-14 | 0 |
Patient 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UDI: LOT/SERIAL UNKNOWN. (B)(4). DEVICE MANUFACTURE DATE: THE DEVICE MANUFACTURE DATE IS UNAVAILABLE. THE MANUFACTURING LOCATION WAS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Patient 1
IT WAS REPORTED FROM (B)(6) THAT DURING A OSTEOSYNTHESIS SURGICAL PROCEDURE FOR THE FEMORAL TROCHANTERIC FRACTURE WITH TFN-ADVANCED PROXIMAL FEMORAL NAILING SYSTEM (TFNA) AND COMPACT AIR DRIVE (CAD) DEVICE IT WAS OBSERVED THAT THE DOUBLE AIR HOSE DEVICE RUPTURED, AND THE CAD WAS UNABLE TO BE USED FOR DRILLING. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING AN UNSPECIFIED SPARE POWER TOOL (ZIMMER DEVICE) IN THE HOSPITAL. IT WAS REPORTED THAT THERE WAS A LESS THAN 30-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.