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 2013-12-26 for PERIOSTEAL ELEVATOR, STRAIGHT SHAFT ROUND EDGE 399.370 manufactured by Synthes Usa.
[4123701]
Device report from synthes (b)(4) reports an event from (b)(6) as follows: it was reported that a chisel was used in an implant removal procedure. The chisel broke during removal of a callus. The case involved a fractured tibia 1/2 shaft distal. This is report 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11452636]
Device is an instrument and is not implanted/explanted. (b)(6). Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn. It is noted there is incomplete information on this form; this event is being investigated. If information is obtained that was not available for the initial medwatch, a follow-up will be filed as appropriate. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-07793 |
| MDR Report Key | 3538315 |
| Report Source | 01,05,07 |
| Date Received | 2013-12-26 |
| Date of Report | 2013-11-27 |
| Date of Event | 2013-10-16 |
| Device Manufacturer Date | 2013-02-27 |
| Date Added to Maude | 2014-04-02 |
| 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 | MARY HABER |
| 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, STRAIGHT SHAFT ROUND EDGE |
| Product Code | HTE |
| Date Received | 2013-12-26 |
| Returned To Mfg | 2013-12-23 |
| Catalog Number | 399.370 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-26 |