MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-06 for 2.0MM MLP BENDER/CUTTER 329.143 manufactured by Synthes Balsthal.
[38214614]
Device was used for treatment, not diagnosis. Device is an instrument and is not implanted/explanted. Device is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device history records was conducted. The report indicates that: 329. 143 - 9642249, manufacturing site: (b)(4), manufacturing date: 04. Sep. 2015, expiry date: - 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. 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
[38214615]
Device report from synthes on an event in (b)(6) as follows: it was reported that during the first operation, part # 329. 143 with lot. 9642249 broke and small piece of the bending part was cut out. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[39598850]
Awareness date was confirmed as (b)(6) 2016. 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 | 3009450863-2016-10002 |
| MDR Report Key | 5414621 |
| Date Received | 2016-02-06 |
| Date of Report | 2016-01-21 |
| Date Mfgr Received | 2016-02-18 |
| Device Manufacturer Date | 2015-09-04 |
| Date Added to Maude | 2016-02-06 |
| 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 | 3 |
| Event Location | 3 |
| 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 | 2016-02-06 |
| Catalog Number | 329.143 |
| Lot Number | 9642249 |
| ID Number | (01)07611819282889(10)9642249 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-02-06 |