MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-11-30 for BOLTCUTTER 388.720 manufactured by Oberdorf Synthes Produktions Gmbh.
[128952615]
Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation. Synthes sales representative a review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis.
Patient Sequence No: 1, Text Type: N, H10
[128952616]
Device report from synthes europe reports an event in argentina as follows: it was reported that on an unknown date, a bolt cutter was broke in the cutting area. It was unknown when the issue observed. It is unknown if there were patient and procedure involvement. This complaint involves one (1) device. This report is 1 of 1 for pc-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2018-58653 |
| MDR Report Key | 8120924 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-13 |
| Date Mfgr Received | 2019-01-10 |
| Device Manufacturer Date | 2017-12-13 |
| Date Added to Maude | 2018-11-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| 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 | BOLTCUTTER |
| Generic Name | CUTTER,WIRE |
| Product Code | HXZ |
| Date Received | 2018-11-30 |
| Returned To Mfg | 2019-01-10 |
| Catalog Number | 388.720 |
| Lot Number | T159279 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-30 |