MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-14 for BLADE/SCREW GUIDE SLEEVE 03.037.017 manufactured by Wrights Lane Synthes Usa Products Llc.
[188833062]
Product complaint # (b)(4). Device returned. Without a lot number, the device history records review could not be completed as no product was received. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. The investigation could not be completed; 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
[188833103]
It was reported that on an unknown date, the blade screw guide sleeve and inserts (buttress/compression nut, wire guide sleeve and trocar) are sticking and having a difficult time assembling. The sterile processing department (spd) was concerned about function and usage due to assembling and proper function during a case. There was no patient involvement. This complaint involves four (4) devices. This report is for one (1) blade/screw guide sleeve. This report is 1 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01279 |
| MDR Report Key | 9832947 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-14 |
| Date of Report | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-14 |
| 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 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLADE/SCREW GUIDE SLEEVE |
| Generic Name | GUIDE |
| Product Code | FZX |
| Date Received | 2020-03-14 |
| Returned To Mfg | 2020-03-11 |
| Model Number | 03.037.017 |
| Catalog Number | 03.037.017 |
| 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 | 2020-03-14 |