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 2018-01-12 for C8302, M ALEXIS WND PROT/RET 5/BX 101355801 manufactured by Applied Medical Resources.
[97791156]
No product is being returned for evaluation and no lot number has been provided to manufacturer. A final report will be sent once the results have been analyzed. This report is in reference to medwatch (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[97791159]
Procedure performed: total hip arthroplasty using [competitor] stem and [competitor] cup received via mail the medwatch (b)(4). "in 2016, customer with a displaced femoral neck fracture underwent a left total hip arthroplasty at this facility. The surgeon performed the procedure described in his note as "complex" and requiring the assistance of a certified physician 's assistant to assist with the retraction and other tasks throughout the procedure. Final sponge and needle counts were correct. The customer tolerated the procedure well and was taken to the recovery room in stable condition. There was no mention of any issues with any of the supplies/instruments used during the procedure. A wound protector/retractor was used during the procedure, but was not inspected when removed from the body. This year, this facility was notified by outside facility that during a left hip revision on this patient, there was a retained foreign object (rfo) located-? -small piece of translucent, thick plastic wrap. The plastic wrap measured approximately 2" by 2". Findings confirmed by their pathology department. The surgeon did disclose to the patient's family that the plastic was not related to the loose implant and had not caused any infection. This surgeon also discussed rfo with surgeon who performed hip initial hip procedure. Both believed the rfo was a piece of the alexis wound protector/retractor, further investigation into the identity of the rfo event at this facility, the surgical team also ruled out supplies, equipment, and the implant as sources for the piece of plastic. The surgical team and surgeon concluded that the rfo was a plastic piece was from the wound proctor/retractor that surgeon uses for hip replacements. Action plan: the surgeon will monitor continued use of the alexis wound protector/retractor ref c8302 for hip replacement procedures. The surgeon prefers this model as it is translucent and allows a clear view of the site and visualization for possible bleeders. It does, however, tear easily. If a wound protector is used for hip replacements, all of the other ortho physicians at this facility use the purple-colored fabric, alexis orthopaedic protector. The wound protection/ retractor device was not part of the surgical count process and was not inspected after removal from the customer ' s body. We will re? -educate all operating room staff on the concept of verifying that all supplies placed in the body are present/inspected for integrity and accounted for. The surgical techs will verify items are intact during the count process. The surgeon has made it part of his practice to inspect the wound protector/retraction device after removal. What was the original intended procedure? : total hip arthroplasty using biomet taperloc stem and g7 cup" patient is a (b)(6) male, not (b)(6). The device is not available for return. Additional information received via email on january 4, 2018 from risk management specialist, at north memorial health: "it is unknown as to this patient's current condition as the patient did not seek medical care for their most recent procedure at our facility. We have no recent records. " "the physician who discovered the retained piece of plastic did remove the plastic piece at the time of discovery during the surgical procedure. It was retained in the pathology dept. At that facility per their policy and procedure, and was destroyed when the required retention time period lapsed. " type of intervention: "the physician who discovered the retained piece of plastic did remove the plastic piece at the time of discovery during the surgical procedure. " patient status: anp
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2018-00019 |
| MDR Report Key | 7186927 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-12 |
| Date of Report | 2018-02-16 |
| Date Mfgr Received | 2018-01-03 |
| Date Added to Maude | 2018-01-12 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C8302, M ALEXIS WND PROT/RET 5/BX |
| Generic Name | KGW |
| Product Code | KGW |
| Date Received | 2018-01-12 |
| Model Number | C8302 |
| Catalog Number | 101355801 |
| Lot Number | UNK |
| 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 EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-12 |