MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-08-31 for SPINAL CURETTE 23-1045, 23-1055 23-1045,23-1055 manufactured by Symmetry Surgical Inc..
[25350796]
Spinal curette complaint received from customer. Customer stated ink was rubbing off the device. The customer noticed when they were setting up the operation room before surgery. The scrub nurse picked up the parts and they had ink rubbing off of them, which contaminated the sterile field. Upon an onsite investigation, it was determined that there was rust. Devices are made from stainless steel, chemical or laser etched, no ink applied to the process of manufacture of this type of device(s). Devices have been sent to the "contract supplier" for further evaluation, expected return will be around the end of (b)(6) 2015. In house inventory was inspected. 100% of the products in inventory were reviewed to look for any signs of rust or discoloration. There were no issues found.
Patient Sequence No: 1, Text Type: N, H10
[25350797]
Spinal curette, customer stated that there was ink rubbing off the device. The customer noticed when they were setting up the operation room before surgery. The scrub nurse picked up the parts and they had ink rubbing off of them, which contaminated the sterile field. Upon an onsite investigation, it was determined that there was rust.
Patient Sequence No: 1, Text Type: D, B5
[66234398]
Follow up report: supplier evaluated the device(s) for initial "ink rubbing off" - supplier evaluation found that the writing dissolves after several sterilization cycles. This is not a defect of the manufacturing of the product. The product was properly labeled and passivated. This is the first complaint for these devices out of (b)(4) sold. Devices have been re-etched and confirmed that the etching does not come off through an autoclave test. Devices were returned to the customer. No further investigation of these devices.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007208013-2015-00019 |
| MDR Report Key | 5053222 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-08-31 |
| Date of Report | 2015-08-24 |
| Date of Event | 2015-07-22 |
| Date Mfgr Received | 2015-07-22 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2015-09-03 |
| 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. VICTORIA ROGERS |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Manufacturer G1 | SYMMETRY SURGICAL INC. |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPINAL CURETTE |
| Generic Name | CURETTE |
| Product Code | FZS |
| Date Received | 2015-08-31 |
| Returned To Mfg | 2015-10-22 |
| Model Number | 23-1045, 23-1055 |
| Catalog Number | 23-1045,23-1055 |
| Lot Number | 121121, 92142224 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC. |
| Manufacturer Address | 3034 OWEN DR ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-31 |