MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-30 for MAYO- HEGAR 7" NEEDLE HOLDER 64-2513 manufactured by Johnson & Johnson (codman Surgical Products).
[15194069]
A (b)(6) female presented on (b)(6) 2011 for a scheduled surgical procedure: revision of it femur nonunion to left hip hemiarthroplasty. Pt tolerated procedure well and course of surgery was uneventful. Routine post-operative films were taken and a 2mm density was seen representing a small foreign body most likely, this density corresponds to an 2mm broken driver tip noted at the end of the surgical procedure, post closure. Surgeon notified, reviewed radiology films and confirmed density. Films re-read by radiologist for confirmation. Needle driver inspected and confirmed broken tip. Needle driver secured by director of surgery. Pt has severe dementia. Foreign body event was fully disclosed to spouse, options discussed, all questions answered. Spouse decided not to return pt to surgery and intentionally retain the foreign body. Surgeon in agreement with spouse's decision as it should not adversely impact the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2400769 |
| MDR Report Key | 2400769 |
| Date Received | 2011-12-30 |
| Date of Report | 2011-12-29 |
| Date of Event | 2011-12-22 |
| Date Facility Aware | 2011-12-22 |
| Report Date | 2011-12-29 |
| Date Reported to FDA | 2011-12-29 |
| Date Reported to Mfgr | 2011-12-29 |
| Date Added to Maude | 2012-01-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAYO- HEGAR 7" NEEDLE HOLDER |
| Generic Name | MAYO NEEDLE HOLDER |
| Product Code | MJG |
| Date Received | 2011-12-30 |
| Model Number | NA |
| Catalog Number | 64-2513 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON (CODMAN SURGICAL PRODUCTS) |
| Manufacturer Address | 501 GEORGE STREET NEW BRUNSWICK NJ 08933 US 08933 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-30 |