MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-05-14 for MALLET 00015500200 manufactured by Zimmer, Inc..
[1548188]
It is reported that the mallet broke.
Patient Sequence No: 1, Text Type: D, B5
[8647308]
Evaluation summary: the mallet has a potential field age of over 14 years and has been used extensively. Cause cannot be definitively determined. Evaluation: device history records indicate all components were manufactured and inspected to specification. (b)(4). Total number of events: 2. Reason for exemption: this mdr is being submitted late, as this issue was identified during a retrospective review of complaint files.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1822565-2010-00295 |
MDR Report Key | 1694840 |
Report Source | 05,08 |
Date Received | 2010-05-14 |
Date of Report | 2007-03-01 |
Date of Event | 2007-03-01 |
Date Mfgr Received | 2007-04-11 |
Device Manufacturer Date | 1992-08-01 |
Date Added to Maude | 2010-09-28 |
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 | BRIAN FIEDLER |
Manufacturer Street | PO 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 | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MALLET |
Generic Name | TRAUMA INSTRUMENT |
Product Code | HXL |
Date Received | 2010-05-14 |
Returned To Mfg | 2007-04-11 |
Model Number | NA |
Catalog Number | 00015500200 |
Lot Number | 43581200 |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ZIMMER, INC. |
Manufacturer Address | P.O. BOX 708 WARSAW IN 46581070 US 46581 0708 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2010-05-14 |