MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-23 for GERZOG MALLET 7-1/2 LEAD 19-790 manufactured by Integra, York - Imiltex.
[2021118]
Customer reported "mallet heads are pitting severely and shavings are coming off during use. This poses a risk to our pts". Additional info received on (b)(6) 2011 from materials manager who reported the mallets are used for hardware implantation and removal as well as striking other instruments such as osteotomes. There were no known injuries. However, the surgeon was concerned that with continued use, bits of metal can only become dislodged from the mallet head and get into the pt's wound.
Patient Sequence No: 1, Text Type: D, B5
[8984803]
The device involved in the reported incident is not available for eval. An investigation has been completed based on the reported info. Part number 19-790 gerzog mallet 7-1/2" (head 8oz) is a lead filled mallet with a stainless steel jacket. The striking surface of the mallet is filled with lead which is a soft metal and will be impacted by normal use. Depending on how the striking surface is making contact not only will the lead be effected but lead shavings could possibly be dislodged. Based on the reported info and the investigation results provided, the root cause is unconfirmed due to no return of device. Integra considers this complaint closed. Future incidents of this nature will be documented for recurrence and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2011-00036 |
| MDR Report Key | 2121899 |
| Report Source | 05,06 |
| Date Received | 2011-05-23 |
| Date of Report | 2011-05-23 |
| Date Mfgr Received | 2011-02-24 |
| Date Added to Maude | 2011-09-20 |
| 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 | CAREN FERNANDEZ |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GERZOG MALLET 7-1/2 LEAD |
| Generic Name | M10 - ORTHOPEDIC |
| Product Code | HXL |
| Date Received | 2011-05-23 |
| Catalog Number | 19-790 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, YORK - IMILTEX |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-23 |