MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-11-20 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.36 manufactured by Synthes (usa).
[18311519]
On (b)(6) 2013, a drill sleeve became stuck with a schanz screw while an external fixation was placed on a male patient. The sleeve and screw were not able to be separated from each other. It was reported that the shaft of the screw appeared to be bent. A larger sleeve with another screw was used to complete the procedure. It was reported that the procedure was delayed six minutes and was successfully completed. The reporter tried unsuccessfully to separate the sleeve and screw on the back table using a periosteal elevator (399. 36) and reduction forceps. In the attempt, the tip of the periosteal elevator and the handle of the reduction forceps were broken. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18398305]
(b)(6). Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. Investigation is on going; no conclusion could be drawn. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-07460 |
| MDR Report Key | 3479058 |
| Report Source | 05,07 |
| Date Received | 2013-11-20 |
| Date of Report | 2013-10-23 |
| Date of Event | 2013-10-23 |
| Date Mfgr Received | 2013-10-23 |
| Date Added to Maude | 2014-02-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH FIGLEAR |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE |
| Product Code | HTE |
| Date Received | 2013-11-20 |
| Returned To Mfg | 2013-11-06 |
| Catalog Number | 399.36 |
| Lot Number | 6022 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2013-11-20 |