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 2020-03-30 for BLADE/SCREW GUIDE SLEEVE 03.037.017 manufactured by Wrights Lane Synthes Usa Products Llc.
[185545151]
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
[185545152]
It was reported that on (b)(6) 2020, during an unknown hip procedure, the trochanteric femoral nail advanced (tfna) helical blade impactor had jammed inside the sleeve. The surgeon used another inserter to force through the trocar in order to finish the case. The surgeon did not use another guide sleeve to complete the procedure. The procedure was successfully completed with 2 minutes surgical delay. There was no adverse consequence on the patient reported. Concomitant devices reported: helical blade inserter (part number 03. 037. 024, lot t116411), insertion instrument: trocar (part number unknown, lot unknown, quantity unknown), nail head elements: tfna helical blade (part number unknown, lot unknown, quantity unknown). This report involves one blade/screw guide sleeve. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01588 |
| MDR Report Key | 9898324 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-30 |
| 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 | 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 | 2020-03-30 |
| Returned To Mfg | 2020-03-26 |
| Model Number | 03.037.017 |
| Catalog Number | 03.037.017 |
| Lot Number | L629391 |
| 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 | 2020-03-30 |