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 2014-11-13 for 2.0MM MLP BENDER/CUTTER 329.143 manufactured by Synthes Balsthal.
[5011964]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the device broke during a veterinary procedure while bending a unilock plate which is normal use. There was no prolongation of the surgery. The surgeon had another device available to use. There was no human patient involvement. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12556237]
Device used in a veterinary case - no patient information will be reported. Additional product code: htz. 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. A review of the device history records has been requested. 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
[12621916]
Additional narrative: 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. Manufacturing evaluation reports, the device returned for inspection with the curved handle is broken off. The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition. The fracture area is homogenous which indicates material conformity. Based on the received information the exact root cause is undetermined. The breakage is possibly indicative of a mechanical overloading situation during usage. The complaint relevant dimensions could not be checked due to the damage conditions. No product fault could be detected. 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 | 3009450863-2014-10044 |
| MDR Report Key | 4247673 |
| Report Source | 01,05,07 |
| Date Received | 2014-11-13 |
| Date of Report | 2014-10-20 |
| Date of Event | 2014-10-14 |
| Date Mfgr Received | 2014-11-24 |
| Device Manufacturer Date | 2008-10-30 |
| Date Added to Maude | 2014-11-13 |
| 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 BALSTHAL |
| Manufacturer Street | DORNACHERSTRASSE 20 |
| Manufacturer City | BALSTHAL CH4710 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4710 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.0MM MLP BENDER/CUTTER |
| Generic Name | INSTR, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2014-11-13 |
| Returned To Mfg | 2014-11-12 |
| Catalog Number | 329.143 |
| Lot Number | 126643 |
| 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 BALSTHAL |
| Manufacturer Address | DORNACHERSTRASSE 20 BALSTHAL CH4710 SZ CH4710 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-13 |