MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for 13.0MM REAMER HEAD FOR RIA 2 STERILE 03.404.022S manufactured by Wrights Lane Synthes Usa Products Llc.
[185542215]
Additional device product code is hrx.. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a synthes employee. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable.. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[185542216]
It was reported that on (b)(6) 2020, during the case the ria2 reamer head came disconnected from the ria2 tube assembly and reamer shaft. The guidewire had to be pulled out which also pulled the reamer head came out. There was damage to the reamer head so it could not be reused. A broken stryker gamma3 nail was removed during the case. A broken screw that was part of the of the broken nail was left behind in the distal femur. The surgeon felt he could ream around but the broken screw hit the reamer head causing the disconnection and damage the reamer head. There were fragments generated from the broken device and removed easily without additional intervention. No broken product was left behind in the patient. The procedure was successfully completed with the use of another ria2 reamer head. There was a 8 minutes surgical delay reported. Concomitant devices reported: ria tube assembly (part unknown, lot unknown, quantity 1), drive shaft f/ria 2 l520 (part 03. 404. 035, lot unknown, quantity 1) guide wire (part unknown, lot unknown, quantity 1), stryker screw (part unknown, lot unknown, quantity 1). This report involves one 13. 0mm reamer head for ria 2 sterile. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01557 |
| MDR Report Key | 9889842 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 13.0MM REAMER HEAD FOR RIA 2 STERILE |
| Generic Name | REAMER |
| Product Code | HTO |
| Date Received | 2020-03-27 |
| Model Number | 03.404.022S |
| Catalog Number | 03.404.022S |
| Lot Number | 33P1506 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |