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 2018-11-05 for CHISEL BLADE 25MM 399.570 manufactured by Wrights Lane Synthes Usa Products Llc.
[126166443]
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter is synthes employee. Without a lot number the device history records review could not be completed. Product was not returned. 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
[126166444]
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, eighteen (18) chisel blades 10mm, fourteen (14) chisel blades 16mm, and six (6) chisel blades 25mm were found in the medical device reprocessing department (mdrd) and tagged as broken. There was no patient or procedure involvement. This report is for one (1) chisel blade 25mm. This is report 1 of 10 for (b)(4). Due to a limit of impacted products per complaint, this complaint is a continuation from complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-54794 |
| MDR Report Key | 8039176 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-05 |
| Date of Report | 2018-10-18 |
| Date Mfgr Received | 2019-01-09 |
| Device Manufacturer Date | 2007-01-13 |
| Date Added to Maude | 2018-11-05 |
| 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 | 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 | 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 25MM |
| Generic Name | CHISEL,SURGICAL INSTRUMENT |
| Product Code | FZO |
| Date Received | 2018-11-05 |
| Returned To Mfg | 2018-11-08 |
| Catalog Number | 399.570 |
| Lot Number | T986800 |
| 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 | 2018-11-05 |