MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-01-02 for SOFT IMPACT MALLET W/ EASY GRIP HANDLES 7832 manufactured by Medtorque Inc..
[4059530]
While in use during surgery, the delrin head of the mallet broke off. The delrin head was found and the device sequestered. No injuries were sustained by the patient. The user facility was informed that the part number had undergone a design change to allow enhanced immobility upon impact. To accomplish this, the re-design incorporated a metal insert within the threads of the heads to create a more tight grip. Note that the design change was already in process when this event occurred. The user facility was issued two loaner devices to use until the design change process was complete. After new devices were manufactured, replacements will be sent to the customer. A follow up message was left regarding the replacement devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1833053-2013-00009 |
| MDR Report Key | 3572125 |
| Report Source | 99 |
| Date Received | 2014-01-02 |
| Date of Report | 2013-12-26 |
| Date of Event | 2013-10-04 |
| Date Facility Aware | 2013-10-09 |
| Report Date | 2013-12-26 |
| Date Reported to FDA | 2013-12-26 |
| Date Reported to Mfgr | 2013-12-26 |
| Date Added to Maude | 2014-01-14 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT IMPACT MALLET W/ EASY GRIP HANDLES |
| Product Code | HXL |
| Date Received | 2014-01-02 |
| Returned To Mfg | 2013-10-13 |
| Model Number | 7832 |
| Catalog Number | 7832 |
| Lot Number | 1012MT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTORQUE INC. |
| Manufacturer Address | KENOSHA WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-02 |