MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for 4.5MM VA LCP INSTRUMENTS AND SCREW SET manufactured by Synthes (usa), Llc.
[41326003]
Patient Sequence No: 1, Text Type: N, H10
[41326004]
Instruments arrived from an outside vendor for a total knee arthroplasty. The tray was noted to be contaminated with visible bioburden of blood, tissue and bone. The tray was the 4. 5mm va lcp instruments and screw set. The 3 items visibly soiled were the 5. 0 cannulated drill bit, the push pull device, and the depth gauge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5531269 |
| MDR Report Key | 5531269 |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-01-18 |
| Report Date | 2016-03-01 |
| Date Reported to FDA | 2016-03-01 |
| Date Reported to Mfgr | 2016-03-01 |
| Date Added to Maude | 2016-03-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.5MM VA LCP INSTRUMENTS AND SCREW SET |
| Generic Name | TRAY, SURGICAL, INSTRUMENT |
| Product Code | HLX |
| Date Received | 2016-03-29 |
| Returned To Mfg | 2016-01-19 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA), LLC |
| Manufacturer Address | 1301 GOSHEN PARKWAY WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-29 |