MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2013-02-14 for MAQUET FEMUR HOOK WITH SUPPORT ARM 1433.42A0 manufactured by Maquet Gmbh And Co. Kg.
[3185445]
During a hip endoprostheses, while the surgeon was raising the femoral hook assembly, a weld failed. No injury or adverse effects to the pt were reported to maquet. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10573215]
Maquet notified the vendor of this unit of the welding issue and they have improved their welding process to prevent recurrence. No devices affected by the weld issue were distributed in the u. S. (b)(4) provided product failure investigation, analysis and resolution for the device described in this report. Exemption # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010652-2013-00006 |
| MDR Report Key | 2970257 |
| Report Source | 01,06,07 |
| Date Received | 2013-02-14 |
| Date of Report | 2013-01-18 |
| Date of Event | 2013-01-17 |
| Date Facility Aware | 2013-02-05 |
| Report Date | 2013-02-14 |
| Date Mfgr Received | 2013-01-18 |
| Date Added to Maude | 2013-04-26 |
| 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 | MS. JANICE PEVIDE |
| Manufacturer Street | 45 BARBOUR POND DR |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097753 |
| Manufacturer G1 | MAQUET GMBH AND CO. KG |
| Manufacturer Street | KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAQUET FEMUR HOOK WITH SUPPORT ARM |
| Generic Name | HOOK, BONE |
| Product Code | KIK |
| Date Received | 2013-02-14 |
| Model Number | 1433.42A0 |
| Catalog Number | 1433.42A0 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET GMBH AND CO. KG |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT 76437 GM 76437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-14 |