MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-09-18 for SCANDIMED OPTIGUN II N/A 419300 manufactured by Biomet Orthopedics.
[3868231]
It was reported patient underwent a hip fracture repair procedure on (b)(6) 2013. During the procedure, the cement gun would not function properly but some bone cement was able to be applied to the femoral canal. Surgeon had difficulty inserting the stem and it became stuck in the patient's femur. While attempting to remove the stem, the patient's femur fractured. As a result, a delay of more than 30 minutes occurred and a competitor's product was utilized to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
[11086602]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: under care and handling of instruments it states, "surgical instruments and instrument cases are susceptible to damage for a variety of reasons including prolonged use, misuse, rough or improper handling. Care must be taken to avoid compromising their exacting performance. " the following sections could not be completed with the limited information provided. Manufacture date? Unknown. Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be sent to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11713076]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: under general warnings it states, "surgeon training and experience: prior to using the bone cement system surgeons should, by specific training and experience, be thoroughly familiar with the properties, handling characteristics, and application of the pmma bone cement. (see precautions and mixing technique) because the handling and curing characteristics of this cement varies with temperature and mixing technique, they are best determined by the surgeon? S actual experience. " examination of returned device found no evidence of product non-conformance. During the evaluation, it was noted the part handle functions but does not flex back completely. The product shows signs of extensive use and wear which is verified by the material analysis. Material analysis identified that the trigger return spring does not have sufficient force to push the trigger back after being actuated. This could be caused by improper cleaning or failure due to age and use. Additionally, review of dhr shows that the instrument has been in use since 2007 and support of material analysis suggest that the instrument was used beyond it useful life.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2013-03800 |
| MDR Report Key | 3354048 |
| Report Source | 07 |
| Date Received | 2013-09-18 |
| Date of Report | 2013-08-19 |
| Date of Event | 2013-08-18 |
| Date Mfgr Received | 2013-08-19 |
| Device Manufacturer Date | 2007-12-11 |
| Date Added to Maude | 2013-09-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGIE DICKSON |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCANDIMED OPTIGUN II |
| Generic Name | EVACUATOR, VAPOR, CEMENT MONOMER |
| Product Code | JDY |
| Date Received | 2013-09-18 |
| Returned To Mfg | 2013-08-26 |
| Model Number | N/A |
| Catalog Number | 419300 |
| Lot Number | 720110 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-09-18 |