MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-12 for AIMING ARM FOR 4.5MM VA-LCP CURVED CONDYLAR PLATE/LEFT 03.231.003 manufactured by Wrights Lane Synthes Usa Products Llc.
[142213761]
Additional device product codes: hrs, hwc. Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: reporter is synthes sales consultant. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[142213762]
It was reported that during on an unknown procedure on an unknown date, the aiming arm instrument and plate did not align accurately. The insertion handle, interlocking bolt, and six (6) locking neutral guide were used to help stabilize a plate and aiming arm to allow the surgeon to do the procedure percutaneously. It is unknown if there was a surgical delay. Procedure and patient outcome are unknown. This report is for one (1) aiming arm for 4. 5mm va-lcp curved condylar plate. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-57453 |
| MDR Report Key | 8511667 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-12 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-03-21 |
| Date Mfgr Received | 2019-05-15 |
| Device Manufacturer Date | 2017-07-13 |
| Date Added to Maude | 2019-04-12 |
| 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 | 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 4.5MM VA-LCP CURVED CONDYLAR PLATE/LEFT |
| Generic Name | IMPLANT,FIXATION DEVICE, CONDYLAR PLATE |
| Product Code | JDP |
| Date Received | 2019-04-12 |
| Model Number | 03.231.003 |
| Catalog Number | 03.231.003 |
| Lot Number | L425543 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-04-12 |