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 2014-05-08 for IN-SITU BENDING & TWISTING HANDLE/120? 03.100.093 manufactured by Synthes Tuttlingen.
[12022509]
A manufacturing evaluation was completed: the instrument was analyzed for conformance to print specifications as well as the device history record was researched, no abnormal findings were identified. The view of the broken surfaces does not show any anomalies of materials structure, what indicates material conformity as well. The investigation of the complained instrument shows that a part of the tip is broken at the welding. Unfortunately we are not able to determine the exact cause which has led to this occurrence. It is likely that too much mechanical force had been applied during the surgery. No product fault could be detected. Device was 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
[20660015]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that part of the instrument was broken while bending a 3. 5 reconstruction plate. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20998580]
Device is an instrument and is not implanted/explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Device was 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 | 9680938-2014-10016 |
| MDR Report Key | 3800728 |
| Report Source | 01,05,07 |
| Date Received | 2014-05-08 |
| Date of Report | 2014-03-31 |
| Date of Event | 2014-03-28 |
| Date Mfgr Received | 2014-05-28 |
| Device Manufacturer Date | 2011-12-14 |
| Date Added to Maude | 2014-06-25 |
| 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 | 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 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 | IN-SITU BENDING & TWISTING HANDLE/120? |
| Generic Name | INSTR, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2014-05-08 |
| Returned To Mfg | 2014-04-24 |
| Catalog Number | 03.100.093 |
| Lot Number | T968408 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-05-08 |