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 2020-03-17 for BLADE/SCREW GUIDE SLEEVE 03.037.017 manufactured by Wrights Lane Synthes Usa Products Llc.
[188680918]
Upon visual inspection no issues were noted that would hinder the functionality of this device. A functional test was not performed as the mating devices the implant were not returned. A definitive root cause for this complaint as its unconfirmed. During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. Device history lot based on picture provided the correct lot# was identified as 9641077 ( not 9841077). Part: 03. 037. 017. Lot: 9641077. Manufacturing site: bettlach. Release to warehouse date: 09 sep 2015. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. 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
[188680919]
It was reported that on an unknown date, prior to an unknown surgery, an inside of blade/screw guide sleeve is damaged preventing the insertion of an unknown helical blade. There was no patient involvement. Concomitant device reported: unknown helical blade (part # unknown, lot # unknown, quantity 1). This report is for one (1) blade/screw guide sleeve. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01303 |
| MDR Report Key | 9842616 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2015-09-09 |
| Date Added to Maude | 2020-03-17 |
| 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, SURGICAL, INSTRUMENT |
| Product Code | FZX |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 03.037.017 |
| Catalog Number | 03.037.017 |
| Lot Number | 9841077 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-17 |