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 2020-03-27 for BLADE/SCREW GUIDE SLEEVE 03.037.017 manufactured by Wrights Lane Synthes Usa Products Llc.
[185543451]
Part 03. 037. 017-us, lot 9485534: manufacturing site: bettlach. Release to warehouse date: may 07, 2015. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. A photo investigation was completed: the images were reviewed, and the complaint condition could be confirmed as damaged threads were seen in the images. Since the device was not returned, a dimensional inspection and a functional test were not able to be performed. A product investigation was completed: upon visual inspection, the external threads were observed to be stripped. The internal hole on the proximal end of the device was observed to be dented and deformed and was missing the red line marking. There were scratches and nicks on the device but has no impact on the functionality of the device. No other issues were identified with the returned device. No functional test was performed as the device was returned by itself. The dimensional inspection was performed on the returned device; the device failed in dimensional inspection due to post manufactured defect. Based on the date of manufacture the relevant drawings, reflecting the current and manufactured revision were reviewed. The external threads of the device received were stripped; hence, confirming the allegation. There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined. The potential root cause could be due to unintended forces applied to the device. The missing epoxy was investigated as well. 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 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
[185543452]
It was reported that on an unknown date, the surgeon noted the triple sleeve in the proximal femoral nailing system (tfna) set was binding and noted damaged threads during the surgery. This was identified during set up, so they had the second set standing by. It is unknown if there was a surgical delay. There was no patient harm and the case went fine. During investigation of the returned device it was noted the internal hole on the proximal end of the device was observed to be dented and deformed and was missing the red line marking. This report is for a blade/screw guide sleeve. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01569 |
| MDR Report Key | 9889256 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-01-27 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2015-05-07 |
| Date Added to Maude | 2020-03-27 |
| 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 | 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 | 2020-03-27 |
| Returned To Mfg | 2020-03-02 |
| Model Number | 03.037.017 |
| Catalog Number | 03.037.017 |
| Lot Number | 9485534 |
| 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 | 2020-03-27 |