MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-08-05 for DRILL GUIDE WITH GRADUATION 388.393 manufactured by Synthes Monument.
[21018030]
Surgeon was drilling with the drill guide with graduation and the sleeve kept pushing down during cervical thoracic fusion. Surgeon noticed that the latch was loose. Surgeon completed the procedure by keeping his thumb on the sleeve.
Patient Sequence No: 1, Text Type: D, B5
[21223598]
Information initially reported to synthes on (b)(6) 2008 and was determined to be not reportable. On (b)(6) 2010, synthes performed a complaint history review and updated the complaint to reportable based on the complaint trend. Date of this report based on the date of the complaint history review. Subject device is an instrument and is not implanted. The device history record was reviewed for this lot and no complaint related anomalies were found. The stem assembly was confirmed to be slipping. During investigation, it was found that the detent and the plunger springs were undersized. It was also found that the detent and plunger springs were swapped in position from the manufacturing specifications. As a result, a corrective action was opened to update the detailed assembly instructions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2010-00199 |
| MDR Report Key | 1804895 |
| Report Source | 05,07 |
| Date Received | 2010-08-05 |
| Date of Report | 2010-07-14 |
| Date of Event | 2008-03-18 |
| Date Mfgr Received | 2010-07-14 |
| Device Manufacturer Date | 2007-07-20 |
| Date Added to Maude | 2011-01-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA HENDRIXSON |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES MONUMENT |
| Manufacturer Street | 1101 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 | 3 |
| Brand Name | DRILL GUIDE WITH GRADUATION |
| Generic Name | DRILL GUIDE |
| Product Code | LXI |
| Date Received | 2010-08-05 |
| Returned To Mfg | 2008-04-14 |
| Model Number | NA |
| Catalog Number | 388.393 |
| Lot Number | 575299F07 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES MONUMENT |
| Manufacturer Address | MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-05 |