MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2016-04-04 for ZIMMER MALLET manufactured by Zimmer Inc.
[41783149]
(b)(4) this report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[41783150]
It is reported that the mallet broke while impacting a trial poly implant during a total knee replacement procedure.
Patient Sequence No: 1, Text Type: D, B5
[46571775]
The product was not returned after multiple attempts to have product returned. The lot number for the product was not provided so a review of the device history records could not be conducted. This device is used in treatment. A complaint history search could not be performed on the part number/lot number combination involved as no lot number was provided for the product. A definitive root cause cannot be determined for the fractured mallet with the information provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1822565-2016-00838 |
| MDR Report Key | 5543735 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2016-04-04 |
| Date of Report | 2016-03-07 |
| Date of Event | 2016-01-19 |
| Date Mfgr Received | 2016-05-11 |
| Date Added to Maude | 2016-04-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KEVIN ESCAPULE |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 465810708 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810708 |
| Manufacturer Phone | 8006136131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER MALLET |
| Generic Name | HXL |
| Product Code | HXL |
| Date Received | 2016-04-04 |
| Lot Number | 00015500200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER INC |
| Manufacturer Address | P.O. BOX 708 WARSAW IN 465810708 US 465810708 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-04 |