MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-20 for PERIOSTEAL ELEVATOR 3MM CURVED BLADE - STRAIGHT EDGE 399.48.96 manufactured by Synthes Tuttlingen.
[24669779]
The current manufacturing location for this part (399. 48. 96) is (b)(4). Without a valid lot number for the specific complainant device, the exact manufacturing location cannot be determined. Device is an instrument and is not implanted or explanted. Investigation could not be completed and no conclusion could be drawn as no device was returned. Without a lot number, the device history record review could not be requested. Device used for treatment, not diagnosis. 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
[24669780]
It was reported that the handle of a periosteal elevator broke into three (3) pieces during a clavical case procedure on (b)(6) 2015. The surgeon indicated that the instrument had been in the field for a long time. The surgeon was able to retrieve all the broken pieces and had another instrument on hand to successfully complete the procedure. No surgical delay or patient harm reported. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[29412648]
Manufacturing location corrected to unknown (synthes usa) as a valid lot number was not provided to determine exact manufacturing site. Device used for treatment, not diagnosis. 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 | 9680938-2015-10076 |
| MDR Report Key | 5017859 |
| Date Received | 2015-08-20 |
| Date of Report | 2015-08-12 |
| Date of Event | 2015-08-11 |
| Date Mfgr Received | 2015-08-20 |
| Date Added to Maude | 2015-08-20 |
| 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 | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES USA |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 3MM CURVED BLADE - STRAIGHT EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2015-08-20 |
| Catalog Number | 399.48.96 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-20 |