MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-03-07 for WIRE, FIXATION, INTRAOSSEOUS manufactured by Synthes (usa).
[4316637]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that on (b)(6) 2014 a proximal femoral nail antirotation was used for an intertrochanteric femoral fracture case. After several checks of the device by assembling with nail before implantation, the nail was inserted. After that, when the guide wire was inserted it then interfered with the nail. The surgeon tried to insert the guide wire again, but the situation did not change. The surgeon removed the nail and did several dry checks again. It was reported that the nail went into the erratic position against the nail hole. At that point, a new guide wire was replaced. After that, the operation was completed as per the normal procedure and without any additional problems. There was a fifteen minute surgical delay reported. This complaint is for 3 of 3 complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11638331]
Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2014-10173 |
| MDR Report Key | 3667848 |
| Report Source | 01,05,07 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-02-06 |
| Date of Event | 2014-01-28 |
| Date Mfgr Received | 2014-02-06 |
| Date Added to Maude | 2014-03-07 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | WIRE, FIXATION, INTRAOSSEOUS |
| Product Code | DZK |
| Date Received | 2014-03-07 |
| 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 | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-07 |