MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for DRILL FLEXIBLE ENDOSCPC CANN 4.5MM 72202971 manufactured by Smith & Nephew, Inc..
[144952709]
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Patient Sequence No: 1, Text Type: N, H10
[144952710]
It was reported that during surgery the drill broke in 2 pieces, all the pieces were removed from the patient. No delay or patient injuries reported, it is unknown how the procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2019-00540 |
| MDR Report Key | 8601798 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-08-09 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-08-08 |
| Device Manufacturer Date | 2016-04-01 |
| Date Added to Maude | 2019-05-10 |
| 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 | DRILL FLEXIBLE ENDOSCPC CANN 4.5MM |
| Generic Name | POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE |
| Product Code | NHB |
| Date Received | 2019-05-10 |
| Returned To Mfg | 2019-08-01 |
| Catalog Number | 72202971 |
| Lot Number | 50594390 |
| 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 | 2019-05-10 |