MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-18 for HANDLE FOR 90? SCREWDRIVER 03.505.004 manufactured by Wrights Lane Synthes Usa Products Llc.
[130898138]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Additional product codes: dzj, hxx. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. The investigation could not be completed; no conclusion could be drawn at the time of filing this report. A review of the device history records has been requested. Device was used for treatment, not diagnosis.
Patient Sequence No: 1, Text Type: N, H10
[130898139]
It was reported that on an unknown date, during an unknown procedure, the 90 degree driver would not lock in screw and kept spinning. It is unknown if there was any surgical delay. There was no patient consequence. This complaint involves one (1) device. This report is 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-55451 |
| MDR Report Key | 8176582 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-18 |
| Date of Report | 2018-11-27 |
| Date Mfgr Received | 2019-01-24 |
| Device Manufacturer Date | 2017-03-16 |
| Date Added to Maude | 2018-12-18 |
| 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 CO 2545 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANDLE FOR 90? SCREWDRIVER |
| Generic Name | DRILL, BONE, POWERED |
| Product Code | DZI |
| Date Received | 2018-12-18 |
| Returned To Mfg | 2018-12-17 |
| Model Number | 03.505.004 |
| Catalog Number | 03.505.004 |
| Lot Number | 8165482 |
| 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 | 2018-12-18 |