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 2018-10-04 for HANDLE WITH QUICK COUPLING, SMALL 311.43 manufactured by Wrights Lane Synthes Usa Products Llc.
[122805627]
Additional narrative: there was no known reported patient involvement associated with the complained event. Unknown when device malfunctioned. The device was received, the investigation is in progress, 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
[122805628]
It was reported that on (b)(6) 2018, it was found out by the sterile processing department that a tap handle for screwdriver was cracked. There was no patient involvement. This complaint involves one (1) device. This report is1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-54177 |
| MDR Report Key | 7936511 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-04 |
| Date of Report | 2018-09-14 |
| Date Mfgr Received | 2018-11-05 |
| Device Manufacturer Date | 2012-11-13 |
| Date Added to Maude | 2018-10-04 |
| 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 | 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 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANDLE WITH QUICK COUPLING, SMALL |
| Generic Name | TREPHINE |
| Product Code | HWK |
| Date Received | 2018-10-04 |
| Returned To Mfg | 2018-10-03 |
| Catalog Number | 311.43 |
| Lot Number | 7067290 |
| 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 | 2018-10-04 |