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 2019-02-15 for BENDING IRON FOR 1.25MM, 1.6MM & 2.0MM KIRSCHNER WIRES 392.000 manufactured by Oberdorf Synthes Produktions Gmbh.
[136278301]
Occupation: initial reporter is synthes sales representative device history lot, part: 392. 000, lot: 2028347, manufacturing site: (b)(4), release to warehouse date: 02. May. 2002. The device history record shows this lot was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted. This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process. Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition. 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
[136278302]
Device report from synthes reports an event in (b)(4) as follows: it was reported that on (b)(6) 2019, they were unable to remove a wire from a bending iron for kirshner wire. It is unknown when the issue was discovered. The procedure outcome is unknown and there was no patient involvement. This report is for one (1) bending iron for 1. 25mm, 1. 6mm & 2. 0mm kirschner wires. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-61051 |
| MDR Report Key | 8343038 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-15 |
| Date of Report | 2019-01-24 |
| Date Mfgr Received | 2019-02-25 |
| Device Manufacturer Date | 2002-05-02 |
| Date Added to Maude | 2019-02-15 |
| 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 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENDING IRON FOR 1.25MM, 1.6MM & 2.0MM KIRSCHNER WIRES |
| Generic Name | INSTR,BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2019-02-15 |
| Catalog Number | 392.000 |
| Lot Number | 2028347 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-02-15 |