MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-07-13 for HEATH HEAVY WEIGHT MALLET 27-0880 manufactured by Symmetry Surgical Formerly Surgical Instrumentation.
[19222514]
During a total hip replacement, the surgeon was using a mallet, when the head of the mallet came off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2012-00002 |
| MDR Report Key | 2666701 |
| Report Source | 06 |
| Date Received | 2012-07-13 |
| Date of Report | 2012-07-12 |
| Date of Event | 2012-05-31 |
| Date Mfgr Received | 2012-06-12 |
| Date Added to Maude | 2012-11-01 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARTIN MOORE |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 6159645392 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEATH HEAVY WEIGHT MALLET |
| Product Code | GFJ |
| Date Received | 2012-07-13 |
| Model Number | 27-0880 |
| Catalog Number | 27-0880 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL FORMERLY SURGICAL INSTRUMENTATION |
| Manufacturer Address | ANTIOCH TN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-13 |