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 2018-11-27 for SHAFT FOR 90? SCREWDRIVER 03.505.003 manufactured by Wrights Lane Synthes Usa Products Llc.
[128419023]
Additional device product codes: dzj, hxx. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. A device history record review 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
[128419024]
It was reported that during an open reduction internal fixation rib case procedure on (b)(6) 2018, the 90-degree screwdriver was spinning slow. After the product was cleaned, the surgeon noticed that the drive shaft was broken. An alternative shaft for 90-degree screwdriver in the set was used, spun at a normal speed, and was able to drill. There was no patient consequence. Patient outcome is unknown. This report is for a shaft for 90-degree screwdriver. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-55105 |
| MDR Report Key | 8105948 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-07 |
| Date Mfgr Received | 2019-01-01 |
| Device Manufacturer Date | 2015-06-08 |
| Date Added to Maude | 2018-11-27 |
| 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 | SHAFT FOR 90? SCREWDRIVER |
| Generic Name | DRILL, BONE, POWERED |
| Product Code | DZI |
| Date Received | 2018-11-27 |
| Returned To Mfg | 2018-11-21 |
| Model Number | 03.505.003 |
| Catalog Number | 03.505.003 |
| Lot Number | 8150502 |
| 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 | 2018-11-27 |