MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2006-08-14 for UNKNOWN K-WIRE manufactured by Depuy Orthopaedics, Inc..
[526931]
The k-wire got stuck in the dedicated distal end of the plate. The surgeon was not able to remove the wire, which got broken into the hole. The surgery delayed approximately 20 minutes.
Patient Sequence No: 1, Text Type: D, B5
[7803224]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2006-02454 |
| MDR Report Key | 771968 |
| Report Source | 01,05,08 |
| Date Received | 2006-08-14 |
| Date of Report | 2006-07-17 |
| Date of Event | 2006-05-16 |
| Date Facility Aware | 2006-07-17 |
| Report Date | 2006-07-17 |
| Date Mfgr Received | 2006-07-17 |
| Date Added to Maude | 2006-10-24 |
| 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 | GINNY STAMBERGER, MGR |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581098 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46581 0988 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN K-WIRE |
| Generic Name | TOTAL FIXATION |
| Product Code | DZK |
| Date Received | 2006-08-14 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 759747 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DR. WARSAW IN 465810988 US |
| Baseline Brand Name | UNKNOWN K-WIRE |
| Baseline Generic Name | TOTAL FIXATION |
| Baseline Model No | NA |
| Baseline Catalog No | UKN |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-14 |