MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for AHTB UNIVERSAL HIP DISTRACTOR 72203270 manufactured by Smith & Nephew, Inc..
[134091358]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[134091359]
It was reported that during the surgery the ball joint on ahtb attachment would not lick in place adequately when the patients leg was in the boot. The surgical assistant had to hold the leg in the required position for the surgeon. No back up device was available. No patient injury or other complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003604053-2019-00007 |
| MDR Report Key | 8275893 |
| Date Received | 2019-01-24 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-03-19 |
| Date Added to Maude | 2019-01-24 |
| 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 | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AHTB UNIVERSAL HIP DISTRACTOR |
| Generic Name | APPARATUS, TRACTION, NON-POWERED |
| Product Code | HST |
| Date Received | 2019-01-24 |
| Returned To Mfg | 2019-02-25 |
| Catalog Number | 72203270 |
| 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 | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-24 |