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 2016-08-16 for PERIOSTEAL ELEVATOR 14MM WIDTH STRAIGHT BLADE 200MM HANDL 03.100.043 manufactured by Synthes Tuttlingen.
[52277580]
Device was used for treatment, not diagnosis. Patient information not available for reporting. Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. Device history records review was conducted. The report indicates that the: part #-03. 100. 043 lot #-5632646 manufacturing date: 16-oct-2007, review of the device history record of (b)(4) showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint. A review of inspection records and certifications, confirm that the, material, components and final product met inspection records, certification. All (b)(4) parts of the lot were checked 100% for ctq features and for function at the final inspection on 15-oct-2007. No ncrs were generated during production. 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
[52277581]
It was reported that during an initial open reduction internal fixation distal tibia surgery on (b)(6) 2016, the handle of the periosteal elevator split or cracked and came off of the shaft and broke during the elevation process. The surgeon used another device that was on-hand and completed the surgery. The procedure was completed successfully with no reports of delay or medical intervention. The patient's post-operative status was noted to be stable. No devices were implanted. He has no patient information. The device will remain with the hospital and will not be sent back to synthes. This complaint has 1 device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680938-2016-10130 |
| MDR Report Key | 5880778 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-16 |
| Date of Report | 2016-08-02 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2016-08-02 |
| Device Manufacturer Date | 2007-10-16 |
| Date Added to Maude | 2016-08-16 |
| 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 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 14MM WIDTH STRAIGHT BLADE 200MM HANDL |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2016-08-16 |
| Catalog Number | 03.100.043 |
| Lot Number | 5632646 |
| ID Number | (01)10886982070920(10)5632646 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-16 |