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 Sa.
[4758243]
Per email received on 04/16/2014 customer reports; during an unk pt procedure, the tip of the reamer handle broke off due to the torque needed to ream the acetabulum. No pt injury or adverse events reported. Surgical delay was not reported.
Patient Sequence No: 1, Text Type: D, B5
[12195466]
Complaint sample was evaluated and the reported failure was confirmed. The marred surfaces near the fracture surface indicated misuse. The locking collar retaining pin welds are cracked. Dhr was reviewed and no discrepancies were found. Manual surgical instruments have a limited life-span which is generally determined by wear or damage due to repeated intended use. No further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614497-2014-00206 |
| MDR Report Key | 4102507 |
| Report Source | 05,08 |
| Date Received | 2014-08-27 |
| Date of Report | 2014-04-16 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-04-16 |
| Device Manufacturer Date | 2010-11-01 |
| 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 | 7639515359 |
| 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 | 2014-04-28 |
| Model Number | 1206-90-10 |
| Catalog Number | T2756 |
| Lot Number | 56505946 |
| 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 SA |
| Manufacturer Address | L' ECHELETTE 7 ORVIN CH-2534 SZ CH-2534 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-27 |