MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-27 for DSTRCTR,ANKLE,GUHL,NON-INVSV. 7207023 manufactured by Smith & Nephew, Inc..
[29968650]
Evaluation was not possible, as the device will not be returned. A review of the device history records and quality records associated with this manufactured lot confirmed that no additional complaints have been filed and that no abnormalities were reported with this product during manufacture. After the evaluation the root cause for the reported issue could not be determined. No further investigation is warranted at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[29968651]
During an ankle arthroscopy, it was reported that the ankle distraction clamp is losing grip. The case was successfully completed with a back-up device and the patient's ankle repositioned. The patient was reported to be okay and no injuries or complications were noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219602-2015-01094 |
| MDR Report Key | 5179618 |
| Date Received | 2015-10-27 |
| Date of Report | 2015-03-31 |
| Date of Event | 2015-03-31 |
| Date Mfgr Received | 2015-04-07 |
| Device Manufacturer Date | 2012-10-11 |
| Date Added to Maude | 2015-10-27 |
| 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 | JAMES GONZALES |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| 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 | DSTRCTR,ANKLE,GUHL,NON-INVSV. |
| Generic Name | COMPONENT, TRACTION, NON-INVASIVE |
| Product Code | KQZ |
| Date Received | 2015-10-27 |
| Catalog Number | 7207023 |
| Lot Number | 50436320 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2015-10-27 |