MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-27 for 11.0MM CANNULATED CUTTER 351.24 manufactured by Wrights Lane Synthes Usa Products Llc.
[93602617]
There was no known reported patient involvement associated with the complained event. Device is an instrument and is not implanted/explanted. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(6). The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[93602618]
Device report from synthes reports an event in canada as follows: it was reported that two cannulated cutter phenolic handles were found to contaminate the instrument set it was put into. There was no patient harm and no delay in procedure. There was no patient involvement reported. This report is for one (1) 11. 0mm cannulated cutter. This is report 2 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2017-50039 |
| MDR Report Key | 7061353 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-27 |
| Date of Report | 2017-10-30 |
| Date Mfgr Received | 2018-03-16 |
| Device Manufacturer Date | 1993-06-17 |
| Date Added to Maude | 2017-11-27 |
| 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 | 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 | BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 11.0MM CANNULATED CUTTER |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2017-11-27 |
| Returned To Mfg | 2018-01-29 |
| Catalog Number | 351.24 |
| Lot Number | A4CC398 |
| 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 CHEATER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-27 |