MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-20 for C8322, XS ALEXIS WND PROT/RET SHRT 5/BX 101432501 manufactured by Applied Medical Resources.
[120969437]
No product is being returned for evaluation but lot # is provided. A device history report is to be reviewed by engineering. A final report will be sent once the results have been analyzed.
Patient Sequence No: 1, Text Type: N, H10
[120969438]
Procedure performed: partial knee arthroplasty. On (b)(6) 2018, c8322 xs alexis wound protector/retractor, lot# 1322872, was used by surgeon at medical center for a partial knee arthroplasty. He knew that the model was not the orthopaedic version but used it anyway. During the procedure, the alexis protector sheath was torn by instrumentation. The staff retrieved the sheath before continuing with the procedure. Surgeon recap of incident: drilled one of the pins through the polyurethane and it wound itself around the pin. Surgeon error! I should have retracted more carefully. All the pieces were wrapped around the pin not loose in the knee. Type of intervention: unknown. Patient status: no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00359 |
| MDR Report Key | 7895055 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-20 |
| Date of Report | 2019-01-14 |
| Date of Event | 2018-08-20 |
| Date Mfgr Received | 2018-08-21 |
| Device Manufacturer Date | 2018-04-17 |
| Date Added to Maude | 2018-09-20 |
| 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 | WENDY KOBAYASHI |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138059 |
| Manufacturer G1 | APPLIED MEDICAL RESOURCES |
| Manufacturer Street | 22872 AVENIDA EMPRESSA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92688 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C8322, XS ALEXIS WND PROT/RET SHRT 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-09-20 |
| Model Number | C8322 |
| Catalog Number | 101432501 |
| Lot Number | 1322872 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESSA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-20 |