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 2020-03-27 for 10.0MM REAMER HEAD FOR RIA 2 STERILE 03.404.016S manufactured by Oberdorf Synthes Produktions Gmbh.
[186531520]
Additional product code hto. Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. (b)(4) used to capture: the reported event required medical/surgical intervention. 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
[186531521]
Device report from synthes reports an event in germany as follows: it was reported on an unknown date that during the surgery while reaming the medullary canal, the reamer head was broke. There were no fragments remaining in the patient. The surgery was completed successfully with 20 minutes delay. There was no patient harm reported. Concomitant device reported: unknown ria assembly tube (part# unknown, lot# unknown, quantity# 1); unknown ria drive shaft (part# unknown, lot# unknown, quantity# 1) this complaint involves one (1) device. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02376 |
| MDR Report Key | 9891772 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2020-01-14 |
| Date Added to Maude | 2020-03-27 |
| 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 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 10.0MM REAMER HEAD FOR RIA 2 STERILE |
| Generic Name | ACCESSORIES, ARTHROSCOPIC |
| Product Code | HRX |
| Date Received | 2020-03-27 |
| Catalog Number | 03.404.016S |
| Lot Number | 26P2098 |
| 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 | 2020-03-27 |