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 2015-06-12 for IN-SITU BENDING & TWISTING HANDLE/120? 03.100.093 manufactured by Synthes Tuttlingen.
[16459682]
Device report from synthes (b)(4) reports an event as follows: it was reported that the tip of the in-situ bending & twisting handle/120? Was discovered to be broken off during central processing. It is unknown when the tip broke off; this event was discovered outside of the operating room. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[16756241]
Additional narrative: device is an instrument and is not implanted or explanted. (b)(6). Subject device has been received; no conclusions could be drawn as the device is entering the complaint system. Device history review: manufacturing date: november 26, 2012. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The raw materials, which were delivered as lots x4n9 and 873247, are corresponding to the specifications. The hardness was measured at the time of manufacturing at 44. 9 hrc and was found to be conforming. The solder between shaft and tip got an additional inspection at the time of manufacturing and was found to be good. No non-conformance reports were generated during production. 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
[30141763]
Additional narrative: an investigation summary was performed. The investigation of the complaint articles has shown that: one in-situ bending and twisting handle, 120 degrees (part number 03. 100. 093, lot number t982342) was received with the complaint category of? Broken: procedural step unknown.? The complaint condition is as the device was received with the distal tip broken off along the weld. The received condition is consistent with excessive force being applied to the distal tip. Given that the broken device was discovered during central processing it is most probable that the method of handling resulted in the complaint condition. However, since it is unknown when the tip broke off and the circumstances at the time of the break the root cause could not be definitively determined. The returned part was determined to be suitable for the intended use when employed and maintained as recommended, the assessment was found to adequately address the complaint condition. Further evaluation at the chu shows that this device is part of the in-situ bending instruments set for the adjustment of pre-contoured reconstruction plates during surgery. Per the technique guide, the system is intended for use with the 3. 5mm low profile reconstruction plates, 3. 5mm wide angle reconstruction plates, and 3. 5mm dcp reconstruction plates. Alternative instruments exist for the locking plates. The returned device was received with the distal tip broken off along the weld. The tip was not returned and it was reported that it is unknown when the tip was broken off. There is a dent on the distal end and the balance is in good condition. Thus, the complaint condition is confirmed but cannot be replicated as the device is already broken. A review of the current design drawing and the drawing revision at the time of manufacture was performed. The design history was found to not impact the complaint condition. The laser weld at the location of the break is specified to a minimum torque of 12nm and, per the device history record review, the solder between shaft and tip got an additional inspection at the time of manufacturing and was found to be good. Thus, the returned part was determined to be suitable for the intended use when employed and maintained as recommended. During the investigation no product design issues or discrepancies were observed that may have contributed to the 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 | 9680938-2015-10049 |
| MDR Report Key | 4840098 |
| Report Source | 01,05,07 |
| Date Received | 2015-06-12 |
| Date of Report | 2015-05-27 |
| Date Mfgr Received | 2015-07-21 |
| Device Manufacturer Date | 2012-11-26 |
| Date Added to Maude | 2015-06-12 |
| 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 | 2015-06-12 |
| Returned To Mfg | 2015-06-05 |
| Catalog Number | 03.100.093 |
| Lot Number | T982342 |
| 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 | 2015-06-12 |