MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-09 for ENDOSCOPIC CANN DRILL BIT 6MM 013499 manufactured by Smith & Nephew, Inc..
[141459170]
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Patient Sequence No: 1, Text Type: N, H10
[141459171]
It was reported that during an acl reconstruction after a guide wire was inserted into femoral bone, the surgeon used the over drilling to make the femoral tunnel, but it was hard to drill. When the guide wire was reinserted, the guide wire broke. No back-up device available and it is unknown if there was delay in the procedure.
Patient Sequence No: 1, Text Type: D, B5
[143583171]
One 013499 endoscopic cannulated 6mm drill bit was returned for evaluation. The complaint stated:? After a guide wire was inserted into femoral bone, the surgeon used the over drilling to make the femoral tunnel, but it was hard to drill. When the guide wire was reinserted, the guide wire broke.? The drill was received with a blockage inside the cannula. There is external damage; the cutting surfaces are scratched, gouged and dulled. As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument. Excessive forces applied to the instrument can result in the instrument? S failure. Do not use these instruments as levers for manipulating hard tissue or bone. Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects. Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges. Bowed or bent guidewires have been found to be a factor for this condition as well. Smith and nephew guide wires are intended for use with this drill bit. It is unknown whether the guidewire was a smith and nephew product. Request for information was unsuccessful. No root cause related to the manufacture of the device was confirmed. There are no other complaints for this manufacturing lot. No further investigation is warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2019-00401 |
| MDR Report Key | 8495745 |
| Date Received | 2019-04-09 |
| Date of Report | 2019-06-12 |
| Date of Event | 2019-04-02 |
| Date Mfgr Received | 2019-06-06 |
| Date Added to Maude | 2019-04-09 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDOSCOPIC CANN DRILL BIT 6MM |
| Generic Name | CULDOSCOPE (AND ACCESSORIES) |
| Product Code | HEW |
| Date Received | 2019-04-09 |
| Returned To Mfg | 2019-04-24 |
| Catalog Number | 013499 |
| Lot Number | USW55060/1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-09 |