MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-15 for DRILL, FLEXIBLE, ENDOSCPC, CANN, 4.5MM 72202971 manufactured by Smith & Nephew, Inc..
[97489708]
Patient Sequence No: 1, Text Type: N, H10
[97489709]
It was reported that the tip of the drill broke during the perforation of the bone tunnel. All parts were removed from the patient, there was no damage to the patient.
Patient Sequence No: 1, Text Type: D, B5
[106885033]
One 4. 5mm flexible endoscopic drill was returned for evaluation. Visual assessment of the drill confirmed the reported breakage. The entire drill head has broken off where it transitions to the double helix of the shaft. There are no material voids at the break area. The break area is slightly uncoiled. Examination of the drill head showed it is heavily burred. Dimensional and material condition was inspected and found to meet print specification. Per the device ifu under precautions? Use of drills that have worn or dull tips can result in breakage?. No root cause related to the manufacturing process can be established. Use error may have been a contributing factor to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2018-00072 |
| MDR Report Key | 7189128 |
| Date Received | 2018-01-15 |
| Date of Report | 2018-02-02 |
| Date of Event | 2017-12-21 |
| Date Mfgr Received | 2018-01-24 |
| Device Manufacturer Date | 2015-02-18 |
| Date Added to Maude | 2018-01-15 |
| 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 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 | DRILL, FLEXIBLE, ENDOSCPC, CANN, 4.5MM |
| Generic Name | POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE |
| Product Code | NHB |
| Date Received | 2018-01-15 |
| Returned To Mfg | 2018-01-19 |
| Catalog Number | 72202971 |
| Lot Number | 50534270 |
| 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 | 2018-01-15 |