MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-31 for JRNY BCS II FEMORAL OXIN LT SZ 5 74022125 manufactured by Smith & Nephew, Inc..
[185719352]
It was reported that surgeon had repeated issues with jii femur packaging. The inner package, on several occasions, has been stuck to the outer packaging making it impossible for the nurse to drop the implant into the sterile field. This requires the inner package to be opened off the field and the? Naked? Implant passed to the field. This added less than a minute delay. The implants were eventually safely passed to the sterile field and implanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2020-01097 |
| MDR Report Key | 9902884 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-31 |
| 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 | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JRNY BCS II FEMORAL OXIN LT SZ 5 |
| Generic Name | PRSTHSISKNEEPTELLFMOROTBLSMI-CNSTRINDCMNTDPOLYMRMTALPLYMR |
| Product Code | JWH |
| Date Received | 2020-03-31 |
| Model Number | 74022125 |
| Catalog Number | 74022125 |
| Lot Number | 19LM14535 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |