MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-07-13 for K-WIRE 10/10 - LENGTH 100 MM * 115100 manufactured by Newdeal S.a..
[591664]
Product id# 115100 is contained in the forefoot set that was shipped by an integra product specialist to the hospital for sterilization in advance of a procedure. The set was clamped together using three trays with individual parts with the k-wire being in the bottom tray. Products in this set are cleaned and sterilized from the last procedure prior to shipment. The integra product specialist reported that it was tightly clamped and wrapped when shipped. The federal express delivery associate who loaded the packages from the carrier's hub reported to the driver to be careful of product poking out of the box. The driver reported to the user facility upon delivery, that his colleague, while loading the box, sustained a puncture wound from the contents of a package. No report of medical intervention has been received. An associate from the materials management department at the hospital accepted the package and observed that the clamp was unhooked on one side of the set and the wire which is 100mm long was sticking out from the box. She contacted the hospital's or of the reported incident, who in turn contacted the integra product specialist, who happened to be at the account to supervise a different procedure. The product specialist reported seeing an empty box with a k-wire at the bottom. The shipping container was taped and appeared damaged. Other instruments included in the shipment appeared acceptable. The integra product specialist was later contacted by the hospital's safety department requesting an investigation and response. The k-wire was not used, and both the product and shipping container are available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[7927723]
An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2006-00019 |
| MDR Report Key | 829074 |
| Report Source | 06,07 |
| Date Received | 2006-07-13 |
| Date of Report | 2006-07-11 |
| Date Mfgr Received | 2006-06-13 |
| Date Added to Maude | 2007-03-21 |
| 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 | 0 |
| Manufacturer Contact | LINDA GOODSTEIN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362269 |
| Manufacturer G1 | NEWDEAL S.A. |
| Manufacturer Street | 10, PLACE D'HELVETIE |
| Manufacturer City | LYON 69006 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | K-WIRE 10/10 - LENGTH 100 MM |
| Generic Name | K-WIRE |
| Product Code | DZK |
| Date Received | 2006-07-13 |
| Model Number | * |
| Catalog Number | 115100 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 816460 |
| Manufacturer | NEWDEAL S.A. |
| Manufacturer Address | * LYON FR |
| Baseline Brand Name | K-WIRE 10/10 - LENGTH 100 MM |
| Baseline Generic Name | K-WIRE |
| Baseline Model No | * |
| Baseline Catalog No | 115100 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-07-13 |