MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-03-08 for HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE 399.68 manufactured by Synthes Gmbh.
[3134906]
A patient was implanted with a 7. 3mm cannulated screw for a scfe about five years ago. The patient complained of discomfort and was taken back to the operation room on (b)(6) 2012, for removal. During the removal process the surgeon used a screwdriver, but the tip stripped out the head of the screw. He then tried a hollow gouge but a piece of the gouge broke off inside the patient and was retrieved. The surgeon then tried the conical extraction screw with the t-handle for quick coupling and the extraction screw stripped and the coupling bent. The surgeon finally used vice grips to get a hold of the screw and removed it. After the procedure the sales consultant went to spd to retrieve the instruments and the screw. Spd did not have the items and it is possible they were discarded. This is report 2 of 2 for this event.
Patient Sequence No: 1, Text Type: D, B5
[10522397]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[11153692]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Original awareness date is (b)(6) 2012. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-10465 |
| MDR Report Key | 2995268 |
| Report Source | 05,07 |
| Date Received | 2013-03-08 |
| Date of Report | 2012-01-27 |
| Date Mfgr Received | 2012-01-27 |
| Date Added to Maude | 2013-05-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | T. MCCARRON |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOLLOW GOUGE FOR BROKEN SCREW EXPOSURE |
| Product Code | GDH |
| Date Received | 2013-03-08 |
| Catalog Number | 399.68 |
| 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 GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-08 |