MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-18 for PIONEER SURGICAL RELEASE LAMINOPLASTY FIXATION SYSTEM, STEAM STERILIZATION CASE 434-222 SAME manufactured by Pioneer Surgical Technology (d.b.a.rti Surgical).
[57931210]
The steam sterilization case was returned to pioneer surgical technology and the latches that hold the case lid in place were very difficult to open and close. The dhr was reviewed and this case was made to pioneer surgical technologies specifications. There have been no reported injuries caused by this steam sterilization case but since there is a remote potential that by opening the lid the user may tear their glove and/or hand pioneer surgical technology is reporting this occurrence.
Patient Sequence No: 1, Text Type: N, H10
[57931211]
During a lab demonstration it was observed by a rti surgical associate product manager that the lid on the steam sterilization kit was difficult to remove and has a potential of ripping a glove if it was used in a clinical setting.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1833824-2016-00035 |
| MDR Report Key | 6037685 |
| Date Received | 2016-10-18 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-09-19 |
| Date Mfgr Received | 2016-09-19 |
| Device Manufacturer Date | 2015-06-19 |
| Date Added to Maude | 2016-10-18 |
| 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 | MR. DAN NELSON |
| Manufacturer Street | 375 RIVER PARK CIRCLE |
| Manufacturer City | MARQUETTE MI 49855 |
| Manufacturer Country | US |
| Manufacturer Postal | 49855 |
| Manufacturer Phone | 9062264489 |
| Manufacturer G1 | PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) |
| Manufacturer Street | 375 RIVER PARK CIRCLE |
| Manufacturer City | MARQUETTE MI 49855 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49855 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PIONEER SURGICAL RELEASE LAMINOPLASTY FIXATION SYSTEM, STEAM STERILIZATION CASE |
| Generic Name | STEAM STERILIZATION CASE |
| Product Code | LRP |
| Date Received | 2016-10-18 |
| Returned To Mfg | 2016-09-29 |
| Model Number | 434-222 |
| Catalog Number | SAME |
| Lot Number | 47140 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PIONEER SURGICAL TECHNOLOGY (D.B.A.RTI SURGICAL) |
| Manufacturer Address | 375 RIVER PARK CIRCLE MARQUETTE MI 49855 US 49855 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-18 |