MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for JOSEPH DOUBLE HOOK 5MM 410152 manufactured by Hebumedical Gmbh.
[98193152]
The device was returned with the broken-off tip. It had been manufactured in august 2011. Review of manufacturing records confirmed device conformance to specs at time of release. Hardness of returned device was tested and found conforming to specifications. The device was subject to microscopic examination. It showed evidence of extensive reuse, such as wear, scratches, and staining in the fracture area. Therefore, fracture due to excessive wear and tear seems to be the most probable cause.
Patient Sequence No: 1, Text Type: N, H10
[98193153]
During an open reduction with internal fixation of the right index finger, the tip of the instrument broke off. The broken piece was retrieved. No delay or injury during case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611112-2018-00001 |
| MDR Report Key | 7206053 |
| Date Received | 2018-01-19 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-12-21 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2018-01-19 |
| 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 | MR. THOMAS BUTSCH |
| Manufacturer Street | BADSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer G1 | HEBUMEDICAL GMBH |
| Manufacturer Street | BADSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JOSEPH DOUBLE HOOK 5MM |
| Generic Name | HOOK |
| Product Code | GDG |
| Date Received | 2018-01-19 |
| Returned To Mfg | 2018-01-10 |
| Catalog Number | 410152 |
| Lot Number | 48 118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEBUMEDICAL GMBH |
| Manufacturer Address | BADSTRASSE 8 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-19 |