MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-05 for 13.0MM CANNULATED DRILL BIT 300MM 351.27 manufactured by Synthes Monument.
[90045559]
Device used for treatment, not diagnosis. Patient age & weight not provided for reporting. Device is an instrument and is not implanted/explanted. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. Device history records review was conducted. The report indicates the: dhr review: part # 351. 27, synthes lot # u110553, supplier lot # u110553. Release to warehouse date: 07 oct 2009. Supplier: (b)(4). No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition. 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
[90045560]
It was reported that a drill bit broke off into a drill chuck during an open reduction internal fixation (orif) intramedullary nail insertion of the femur on (b)(6) 2017. The drill bit broke into two pieces as the surgeon was drilling. The drill used was a stryker 7000. There was no reported surgical delay. Fragments did fall into the patient; but,were reported as easily removed and caused no delay or internal damage. The surgery was successfully completed using a new drill bit. A nail and (4) 5. 0mm locking screws were implanted in the patient after the drill bit broke. The patient outcome was reported as great. A replacement was requested. Concomitant devices reported: a stryker 7000 drill (part number: unknown, lot number: unknown, quantity: 1). This report involves 1 device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1719045-2017-11013 |
| MDR Report Key | 6915569 |
| Date Received | 2017-10-05 |
| Date of Report | 2017-09-14 |
| Date of Event | 2017-09-14 |
| Date Mfgr Received | 2017-11-08 |
| Device Manufacturer Date | 2009-10-07 |
| Date Added to Maude | 2017-10-05 |
| 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 MONUMENT |
| Manufacturer Street | 1051 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 13.0MM CANNULATED DRILL BIT 300MM |
| Generic Name | INSTR,SURGICAL,ORTHO,PNEUMATIC POWERED & ACCESSORY/ATTACHMENT |
| Product Code | HSZ |
| Date Received | 2017-10-05 |
| Returned To Mfg | 2017-09-22 |
| Catalog Number | 351.27 |
| Lot Number | U110553 |
| 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 MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-05 |