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 AIMING ARM FOR SUPRAPATELLAR 03.010.441 manufactured by Wrights Lane Synthes Usa Products Llc.
[185909071]
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
[185909072]
It was reported on (b)(6) 2020, during an unknown procedure, while the surgeon was using the aiming arm for suprapatellar for proximal interlocks on an expert tibial nail, the drill missed the locking hole through the targeted guide and hit the nail. The guide and drill were removed by utilizing the perfect circles technique. Surgical delay and procedure outcome are unknown. There was no patient consequence. Concomitant devices reported: cann connections scr f/percutan instruments for nails-ex(part number 03. 010. 404, lot u261953, quantity 1), insertion handle suprapatellar(part number 03. 010. 440, lot 180183-101, quantity 1), drill bits: trauma (unknown part number, unknown lot, quantity 1), nails (unknown part number, unknown lot, quantity 1). This report involves one (1) aiming arm for suprapatellar. This is report 1 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01604 |
| MDR Report Key | 9899661 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| 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 | SYNTHES SELZACH |
| Manufacturer Street | BOHACKERWEG 5 |
| Manufacturer City | SELZACH 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIMING ARM FOR SUPRAPATELLAR |
| Generic Name | NAIL,FIXATION,BONE |
| Product Code | JDS |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 03.010.441 |
| Catalog Number | 03.010.441 |
| Lot Number | 170039-202 |
| 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 |