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 2014-03-07 for 2.0MM MLP BENDER/CUTTER 329.143 manufactured by Synthes Balsthal.
[4480738]
Device report is from synthes (b)(4) reporting an event in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[11855201]
Additional narrative: the manufacturing documents were reviewed and no complaint related issues were found. A manufacturing evaluation was completed: the product was received with the bending nose of cutting/bending instrument broken off. The bending nose broke starting from the transition radius of the nose, crossing the central bore of the joint and terminating in the cutting feature of the instrument. The instrument was launched initially in 2002. In (b)(6) 2006 the design, especially the transition radius between the joint housing and nose was changed. 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
[15879104]
Device was used for treatment, not diagnosis. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[15931288]
The cutting tip of the plier came off during cutting of a veterinary unilock plate 2. 0. No excessive force was ued. No patient was involved. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009450863-2014-10002 |
| MDR Report Key | 3667617 |
| Report Source | 01,05,07 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-02-06 |
| Date of Event | 2014-02-06 |
| Date Mfgr Received | 2014-02-20 |
| Device Manufacturer Date | 2012-03-09 |
| Date Added to Maude | 2014-05-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | INSTRUMENT, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2014-03-07 |
| Returned To Mfg | 2014-03-11 |
| Catalog Number | 329.143 |
| Lot Number | 7802342 |
| Operator | OTHER HEALTH CARE 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 | 2014-03-07 |