MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-03 for INLINE DRILL GUIDE-SPIKE TIP 2.3 72201110 manufactured by Smith & Nephew.
[1194801]
Tip of the inline drill guide broke off in patient during hip arthroscopy. Md spent 45 min trying to retrieve it and eventually left it alone since it was outside of the capsule. Pt was informed by md post op of retained foreign body. Dates of use: 2009. Diagnosis or reason for use: hip arthroscopy. Event abated after use stopped: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011302 |
| MDR Report Key | 1399141 |
| Date Received | 2009-06-03 |
| Date of Report | 2009-06-03 |
| Date of Event | 2009-05-27 |
| Date Added to Maude | 2009-06-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INLINE DRILL GUIDE-SPIKE TIP 2.3 |
| Generic Name | DRILL GUIDE |
| Product Code | LXI |
| Date Received | 2009-06-03 |
| Catalog Number | 72201110 |
| Lot Number | 50280106 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW |
| Manufacturer Address | 150 MINUTEMAN RD ANDOVER MD 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-03 |