MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2008-10-29 for ELITE VANGUARD SLIDEX FEMORAL BLOCK N/A 32-485153 manufactured by Biomet Inc..
[967671]
It was reported that patient underwent total knee arthroplasty procedure in 2008. During procedure, pin from cutting block fell out of the block and into the patient's wound. Pin was retrieved from patient.
Patient Sequence No: 1, Text Type: D, B5
[1016762]
It was reported that patient underwent total knee arthroplasty procedure 2008. During procedure, pin from cutting block fell out of the block and into the patients wound. Pin was retrieved from patient.
Patient Sequence No: 1, Text Type: D, B5
[8163792]
Examination of returned device confirmed reported condition. In response to reported event, health hazard evaluation was conducted and recall was initiated to rework the instruments. This report filed january 23, 2009
Patient Sequence No: 1, Text Type: N, H10
[8233564]
The user facility is outside of the united states. No medwatch report was received. No user facility information is available. Current information is insufficient to permit a conclusion as to the cause of the event. There have been no trends identified related to this type of event. Event date: 2008. Evaluation in process, but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1825034-2008-00287 |
| MDR Report Key | 1213165 |
| Report Source | 01,07 |
| Date Received | 2008-10-29 |
| Date of Report | 2008-10-03 |
| Date Mfgr Received | 2008-10-03 |
| Device Manufacturer Date | 2007-11-17 |
| Date Added to Maude | 2009-01-23 |
| 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 | MS. KIM WALGAMUTH |
| Manufacturer Street | P.O. BOX 587 |
| Manufacturer City | WARSAW IN 465810587 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810587 |
| Manufacturer Phone | 5742676639 |
| Manufacturer G1 | BIOMET INC. |
| Manufacturer Street | P.O. BOX 587 |
| Manufacturer City | WARSAW IN 46581058 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0587 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1825034-12/23/08-013-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE VANGUARD SLIDEX FEMORAL BLOCK |
| Generic Name | INSTRUMENT, ALIGNMENT DEVICE |
| Product Code | IQO |
| Date Received | 2008-10-29 |
| Returned To Mfg | 2008-10-13 |
| Model Number | N/A |
| Catalog Number | 32-485153 |
| Lot Number | 132502 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET INC. |
| Manufacturer Address | P.O. BOX 587 WARSAW IN 46581058 US 46581 0587 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-10-29 |