MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-09-30 for STERILE SURGICAL MARKING SYSTEMS Q100 manufactured by Medical Action Industries, Inc..
[17610940]
(see medwatch (b)(4) for customer's exact verbiage). During a total knee replacement, the operating room staff removed the tip from the surgical marking pen, attached it to a hemostat and inserted it in the distal femoral area to mark the bone as a guide for inserting pins. At one point, they realized the tip was lost in one of the holes. After copious irrigation and multiple attempts to retrieve the tip, they were unable to remove it. The operating room staff reasoned that the marker tip was deep in the bone and would be sealed by the bone cement and would not cause further problems.
Patient Sequence No: 1, Text Type: D, B5
[17758304]
On (b)(4) 2013, mai received a complaint from our customer, (b)(4) (distributor) along with medwatch (b)(4) for an incident involving our surgical marking pen, q100. The pen lot number was not available. Mai immediately opened complaint (b)(4) for this issue. Mai does not make the pen, but rather purchases it, then repackages and relabels it. Per the original medwatch event narrative, the operating room staff actually removed the marking tip from the pen's casing and secured it to a hemostat to mark the distal pin holes for the procedure. They stated that "the tip of the marking pen is not long enough if used as intact in the marking pen. This process of removing the actual marking pen tip is not an unusual standard of practice and is used in other hospitals... " despite this statement, the operating room staff is not following best practice since they are not using the pen according to its intended, approved use, which is to use the pen without disassembling it. The tip of the mai marking pens should never be removed from the casing nor should the pen be disassembled; rather, the cap should be removed from the pen and the pen used to mark the surgical area. Mai does not offer any pens with a longer tip that would accommodate this customer's requirements and suggested that (b)(4) explore other pen options with them. Mai has sold this product for many years; this is the first complaint of this nature for any of our pens. We will continue to track for any related trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030451-2013-00007 |
| MDR Report Key | 3434877 |
| Report Source | 00,05 |
| Date Received | 2013-09-30 |
| Date of Report | 2013-09-26 |
| Date of Event | 2013-05-23 |
| Date Mfgr Received | 2013-09-05 |
| Date Added to Maude | 2013-11-27 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEBORAH KLOOS, DIRECTOR |
| Manufacturer Street | 25 HEYWOOD RD. |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal | 28704 |
| Manufacturer Phone | 8286818820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILE SURGICAL MARKING SYSTEMS |
| Generic Name | SURGICAL MARKING PENS |
| Product Code | HRP |
| Date Received | 2013-09-30 |
| Model Number | Q100 |
| Catalog Number | Q100 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES, INC. |
| Manufacturer Address | 25 HEYWOOD RD. ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-30 |