MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-10-03 for ZIMMER MALLET 00015500200 manufactured by Zimmer, Inc..
[56175892]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[56175893]
It is reported that rust was found on a new instrument prior to use.
Patient Sequence No: 1, Text Type: D, B5
[60780997]
Patient Sequence No: 1, Text Type: N, H10
[65940364]
This follow-up report is being filed to correct information. Upon reassessment of the reported event, it was determined to not be reportable. This malfunction has not been previously reported in same or similar devices.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001822565-2016-03476 |
| MDR Report Key | 5993277 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-10-03 |
| Date of Report | 2016-09-07 |
| Date of Event | 2016-08-31 |
| Date Mfgr Received | 2017-01-06 |
| Device Manufacturer Date | 2015-06-15 |
| Date Added to Maude | 2016-10-03 |
| 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 | MS. CARRIE SCHNEIDER |
| Manufacturer Street | P.O. BOX 708 |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal | 46580 |
| Manufacturer Phone | 8006136131 |
| Manufacturer G1 | ZIMMER, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER MALLET |
| Generic Name | TRAUMA INSTRUMENT |
| Product Code | HXL |
| Date Received | 2016-10-03 |
| Returned To Mfg | 2016-10-31 |
| Catalog Number | 00015500200 |
| Lot Number | 63094544 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-03 |