MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-08-27 for ACETABULAR REAMER SHAFT 1206-90-10 T2756 manufactured by Greatbatch Medical Sa.
[4715303]
Per email received on (b)(4) 2014 customer reports; during an unk procedure on a pt (unk age nad gender) the surgeon was reaming acetablum when the reamer snapped at the juncture for the quick connect. No pt injury or adverse events reported. Surgery was completed with another device.
Patient Sequence No: 1, Text Type: D, B5
[12174925]
Complaint sample was evaluated and the reported event was confirmed. Failure mode is an impact type failure mode indicating that this part may have been subjected to some misuse. Dhr was not reviewed. Manual surgical instruments have a limited life-span which is generally determined by wear or damage due to repeated intended use. No further investigation required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614497-2014-00207 |
| MDR Report Key | 4102508 |
| Report Source | 05,08 |
| Date Received | 2014-08-27 |
| Date of Report | 2014-06-04 |
| Date of Event | 2014-04-04 |
| Date Mfgr Received | 2014-06-04 |
| Date Added to Maude | 2014-09-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JENNIFER MENG |
| Manufacturer Street | 2300 BERSHIRE LN NORTH |
| Manufacturer City | MINNEAPOLIS MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| Manufacturer Phone | 7639518359 |
| Manufacturer G1 | GREATBATCH MEDICAL SA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACETABULAR REAMER SHAFT |
| Generic Name | REAMER HANDLE |
| Product Code | EJB |
| Date Received | 2014-08-27 |
| Returned To Mfg | 2014-06-06 |
| Model Number | 1206-90-10 |
| Catalog Number | T2756 |
| Lot Number | 75146400 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GREATBATCH MEDICAL SA |
| Manufacturer Address | L' ECHELETTE 7 ORVIN CH-2534 SZ CH-2534 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-27 |