MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-23 for INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM 03.010.473 manufactured by Wrights Lane Synthes Usa Products Llc.
[185948510]
Reporter is a synthes employee. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[185948511]
It was reported that on (b)(6) 2020 the tip of the two (2) inter-lock screw drivers were noticed to have bent and twisted. The issue was discovered during the assembling of trays in the central processing department. There were no patient or surgical involvement. Concomitant device: unknown trays (part unknown, lot # unknown, quantity unknown). This report is for one inter-lock screwdriver t25/ 3. 5mm hex/ 224mm. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01475 |
| MDR Report Key | 9868097 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-23 |
| 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 | WERK H |
| 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 | INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM |
| Generic Name | SCREWDRIVERS |
| Product Code | HXX |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 03.010.473 |
| Catalog Number | 03.010.473 |
| Lot Number | 1L54567 |
| 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 | 2020-03-23 |