MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-08-24 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.36 manufactured by Synthes (usa).
[52858201]
Device was used for treatment, not diagnosis. (b)(4). Device is an instrument and is not implanted/explanted. The subject device is not expected to be returned to the synthes manufacturer for evaluation. 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. 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
[52858202]
It was reported that during a procedure to repair a fractured distal clavicle acromioclavicular (ac) joint on (b)(6) 2016, while inserting a 3. 5mm locking compression plate (lcp) plate, the handle of a 6mm periosteal elevator broke apart in the surgeon's hand, cutting the surgeon's glove. The handle of the device broke into two pieces; approximately 25 percent of the handle was still attached to the device and approximately 75 percent broke off. There was a one (1) minute delay while the surgeon re-gloved and obtained another device. The surgery was successfully completed with an alternate instrument with no harm to the patient or the surgeon. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2016-14333 |
| MDR Report Key | 5899882 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-24 |
| Date of Report | 2016-08-09 |
| Date of Event | 2016-08-09 |
| Date Mfgr Received | 2016-08-09 |
| Date Added to Maude | 2016-08-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2016-08-24 |
| Catalog Number | 399.36 |
| 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 | 2016-08-24 |