MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for INSERTER/EXTRACTOR FOR CHILD & ADOLESCENT OSTEOTOMY PLATES 332.353 manufactured by Wrights Lane Synthes Usa Products Llc.
[185915698]
(b)(6). The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[185915699]
It was reported on (b)(6) 2020, it was noticed that both screws in the two (2) inserter/extractor for child hip plate were bound or cross-threaded making them unusable. The sales consultant attempted to unscrew the one in the infant inserter/extractor, but the screw head snapped off. This did not impact a surgery, as the sales consultant was checking the set beforehand. There was no patient involvement. This report involves one (1) inserter/extractor for child & adolescent osteotomy plates. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01517 |
| MDR Report Key | 9882469 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSERTER/EXTRACTOR FOR CHILD & ADOLESCENT OSTEOTOMY PLATES |
| Generic Name | EXTRACTOR |
| Product Code | HWB |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 332.353 |
| Catalog Number | 332.353 |
| Lot Number | 7930179 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |