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 2019-01-16 for CHISEL BLADE 10MM 399.55 manufactured by Wrights Lane Synthes Usa Products Llc.
[133335468]
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Reporter is synthes sales consultant. A review of the device history records has been requested. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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
[133335469]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, one (1) chisel blade w/ 10, one (1) chisel blade w/ 16 and one (1) periosteal elevator 6mm curved blade - straight edge were marked as broken in medical device reprocessing department (mdrd). The tip of the two (2) chisel blades were uneven and dull. The tip of the periosteal elevator was dinged and dull. There was no patient and procedure involvement. This report is for one (1) chisel blade 10mm. This is report 1 of 3 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-55900 |
| MDR Report Key | 8254988 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-16 |
| Date of Report | 2018-12-27 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2018-05-25 |
| Date Added to Maude | 2019-01-16 |
| 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 TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHISEL BLADE 10MM |
| Generic Name | CHISEL, SURGICAL INSTRUMENT |
| Product Code | FZO |
| Date Received | 2019-01-16 |
| Returned To Mfg | 2019-01-21 |
| Model Number | 399.55 |
| Catalog Number | 399.550 |
| Lot Number | T168610 |
| 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 | 2019-01-16 |