MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-18 for AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING 03.010.051 manufactured by Wrights Lane Synthes Usa Products Llc.
[188675235]
Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is synthes rep. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. A review of the device history record has been requested. 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
[188675236]
It was reported that on (b)(6) 2020, an aiming arm for retrograde spiral blade locking and spiral blade inserter for retrograde femoral nail were jammed during an unknown procedure. It is unknown if there was a surgical delay. Procedure outcome is unknown. There was no incident to the patient. This complaint involves (2) devices. This report is 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01332 |
| MDR Report Key | 9850559 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2008-05-06 |
| Date Added to Maude | 2020-03-18 |
| 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 | SYNTHES HAEGENDORF GMBH-CN |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIMING ARM FOR RETROGRADE SPIRAL BLADE LOCKING |
| Generic Name | GUIDE |
| Product Code | FZX |
| Date Received | 2020-03-18 |
| Model Number | 03.010.051 |
| Catalog Number | 03.010.051 |
| Lot Number | 1842895 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-18 |