MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-11-27 for EXTERNAL FIXATOR manufactured by Synthes Usa.
[3000088]
A device report from (b)(4) indicated a hospital in (b)(6) reported: patient had external fixation for femoral fracture in (b)(6) 2012. It was discovered the patient had a nonunion. The external fixation was removed a few days before the revision surgery, date unknown. The revision took place on (b)(6) 2012. During the revision, surgeon was reaming and was having difficulty with the reamer head and shaft. Surgeon tries several times to pass the reamer in the femoral canal without success. Surgeon then decided to ream the spinal canal to take graft. Experiences difficulty with passing the reamer head but tries until he succeeded. It was observed through x-rays the reamer head is broken in the distal part and is in the milling guide. This is 3 of 3 reports for this complaint event.
Patient Sequence No: 1, Text Type: D, B5
[10344036]
Implanted (b)(6) 2012. 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2012-03411 |
| MDR Report Key | 2847004 |
| Report Source | 01,07 |
| Date Received | 2012-11-27 |
| Date of Report | 2012-10-29 |
| Date of Event | 2012-10-11 |
| Date Mfgr Received | 2012-10-29 |
| Date Added to Maude | 2012-11-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHERRY LAING |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | EXTERNAL FIXATOR |
| Product Code | JEC |
| Date Received | 2012-11-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-11-27 |