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 2019-01-24 for WIRE CUTTER 220MM 391.930 manufactured by Oberdorf Synthes Produktions Gmbh.
[134061245]
Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: reporter is a synthes employee. Part: 391. 930; lot: 5150; manufacturing site: (b)(4). Device history record (dhr) not available as device is older than fifteen (15) years. At this time the manufacturing documents for instruments had to be stored for 10 years. This was according to sop (filing and archiving of specification documents), which was in place unit august 2014. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[134061246]
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2018, the wire cutter large with cantilever was noted to have a distortion of the cutting edge. It was unknown when the issue occurred. There was no patient involvement. This report is for a wire cutter 220mm. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-60304 |
| MDR Report Key | 8275843 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-24 |
| Date of Report | 2018-11-11 |
| Date Mfgr Received | 2019-01-07 |
| Date Added to Maude | 2019-01-24 |
| 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 | 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 SALZBURG |
| Manufacturer Street | VORGARTENSTRASSE 206B |
| Manufacturer City | WIEN 1020 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 1020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WIRE CUTTER 220MM |
| Generic Name | CUTTER, WIRE |
| Product Code | HXZ |
| Date Received | 2019-01-24 |
| Catalog Number | 391.930 |
| Lot Number | 5150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-01-24 |