MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-11-10 for TRANSVERSE DRILL GUIDE 0234500202 manufactured by Stryker Endoscopy San Jose.
[1675737]
It was reported that the transverse drill guide was used first time when the screw jammed. It was further stated that the surgeon had to use forceps to unlock the screw.
Patient Sequence No: 1, Text Type: D, B5
[8900522]
Add'l info will be provided once investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936485-2010-00828 |
| MDR Report Key | 1900930 |
| Report Source | 05 |
| Date Received | 2010-11-10 |
| Date of Report | 2010-10-11 |
| Date of Event | 2010-09-28 |
| Date Mfgr Received | 2010-10-11 |
| Date Added to Maude | 2011-06-23 |
| 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 | SUNNY OFFORJEBE |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal | 95138 |
| Manufacturer Phone | 4087542000 |
| Manufacturer G1 | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Street | 5900 OPTICAL CT. |
| Manufacturer City | SAN JOSE CA 95138 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95138 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSVERSE DRILL GUIDE |
| Generic Name | DRILL GUIDE |
| Product Code | LXI |
| Date Received | 2010-11-10 |
| Catalog Number | 0234500202 |
| Lot Number | 34376 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER ENDOSCOPY SAN JOSE |
| Manufacturer Address | SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-10 |