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 2017-09-28 for 14.0MM CANNULATED AWL 03.010.041 manufactured by Synthes Hagendorf.
[87727625]
Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. Dhr review was completed. Manufacturing location: (b)(4). Manufacturing date: 19. Sep. 2008. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. Device was used for treatment, not diagnosis. 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
[87727626]
It was reported that a patient underwent a femoral nailing due to a football injury. Upon opening the patient's proximal femur, it was noted that he had extremely hard bone so the surgeon used a 14. 0 mm cannulated awl after the opening reamer wouldn't advance. After sinking the 14. 0 mm cannulated awl it was noted that a piece of the awl broke off in the bone. The surgeon decided not to retrieve the piece and the surgery wasn't delayed. Then, when locking the nail proximally, the drill sleeves didn't pass through the handle easily, and they were difficult to remove. There wasn't a considerable delay due to this, but the surgeon mentioned how difficult it was to pass the sleeves. Concomitant device reported: drill sleeves, unknown nail. This report is for one (1) 14. 0 mm cannulated awl. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003875359-2017-10480 |
| MDR Report Key | 6901821 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-09 |
| Date Mfgr Received | 2017-10-26 |
| Device Manufacturer Date | 2008-09-19 |
| Date Added to Maude | 2017-09-28 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES HAGENDORF |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAGENDORF CH4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 14.0MM CANNULATED AWL |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2017-09-28 |
| Returned To Mfg | 2017-09-20 |
| Catalog Number | 03.010.041 |
| Lot Number | 1989312 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES HAGENDORF |
| Manufacturer Address | IM BIFANG 6 HAGENDORF CH4614 SZ CH4614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-28 |