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 2018-10-03 for 3.5MM LCP? PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM 241.901 manufactured by Wrights Lane Synthes Usa Products Llc.
[122638873]
Patient weight not provided for reporting. Not implanted or explanted. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. A review of the device history records has been requested and is currently pending completion. Device was used for treatment, not diagnosis.
Patient Sequence No: 1, Text Type: N, H10
[122638874]
It was reported that during an orthopedic procedure on (b)(6) 2018, while the surgeon placed cannulated locking screws into the head of the 3 hole proximal humerus plate, the locking screws did not lock into the plate on 2 separate occasions with 2 separate screws. The surgeon used the screwdriver shaft with torque limiting attachment on a power driver to insert the screws. While doing the final locking by hand, the screws continued to turn in the holes as if they had been stripped out. The plate and screws were removed and replaced with a new plate and locking screws were inserted. The new screws locked into the new plate accordingly. It is unknown if there was a surgical delay. There was no patient consequence reported. Concomitant devices reported: unknown screwdriver shaft (part # unknown, lot # unknown, quantity 1), unknown torque limiting attachment (part # unknown, lot # unknown, quantity 1), unknown power driver (part # unknown, lot # unknown, quantity 1). This report is for one (1) 3. 5mm lcp? Proximal humerus. Plate-standard 3h shaft/90mm. This complaint involves two (2) devices. This report is 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-54139 |
| MDR Report Key | 7932366 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-03 |
| Date of Report | 2018-09-12 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-11-05 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2018-10-03 |
| 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 | MR. MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK RARON (CH) |
| Manufacturer Street | KANALSTRASSE WEST 30 |
| Manufacturer City | RARON 3942 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 3942 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM LCP? PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-10-03 |
| Returned To Mfg | 2018-09-28 |
| Model Number | 241.901 |
| Catalog Number | 241.901 |
| Lot Number | L657200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-10-03 |