MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-03-18 for ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES manufactured by Synthes (usa).
[17385408]
Attorney advised that a male patient underwent an open reduction internal fixation of the left patella on (b)(6) 2012. In the placement of the locking bolt, the bolt bound up and could not be removed. It was reported that the doctor inspected the back table which showed metal shavings where the locking bolt and nail were originally placed. The set screw was fully deployed or deployed distally which caused binding of the blade through the nail. During the attempted removal of the nail and bound blade, the lateral cortex of the patient split approximately half the length of the femur. This is report 4 of 4 for (b)(4). This report is for an unknown blade.
Patient Sequence No: 1, Text Type: D, B5
[17776341]
This report is for an unknown blade. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[27587246]
Device was used for treatment, not diagnosis. This medwatch is being rescinded. The complaint was reviewed on 05/05/2014 and determined to be a duplicate complaint of an existing catsweb complaint management system complaint (b)(4). Complaint (b)(4) was previously reported through mfr# 3003506883-2012-00168. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2014-10330 |
| MDR Report Key | 3686290 |
| Report Source | 07 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-02-21 |
| Date of Event | 2012-03-28 |
| Date Mfgr Received | 2014-05-05 |
| Date Added to Maude | 2014-03-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES |
| Product Code | HBS |
| Date Received | 2014-03-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-18 |