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 |