MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for SYNFIX? EVOLUTION SCREWDRIVER 03.835.010 manufactured by Wrights Lane Synthes Usa Products Llc.
[185919498]
Reporter is synthes employee. A product investigation was conducted. Visual inspection: the synfix evolution screwdriver (p/n: 03. 835. 010, lot #: 9939889) was returned and received at us cq. Upon visual inspection, it was observed that the distal tip of the screwdriver shaft was stripped. There were scratches on the device but has no impact on the functionality of the device. The noted defect is consistent as a potential end of life indicator for the device. No other issues were identified with the returned components of the device. Investigation conclusion: the stripped condition of the driver tip is a potential end of life indicator of the screwdriver. After a visual inspection, it is determined that the reusable instrument is worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required. During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities. A device history record (dhr) review was conducted: part number: 03. 835. 010, lot number: 9939889. A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required. 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
[185919499]
It was reported that on an unknown date, during a routine incoming inspection of a loaner set, it was observed that a synfix evolution screwdriver was non-functional. There was no known patient or hospital involvement. During manufacturer's investigation on february 28, 2020 of the returned device it was identified that the distal tip of the screwdriver shaft was stripped. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01528 |
| MDR Report Key | 9881213 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-12 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-25 |
| 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 | ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNFIX? EVOLUTION SCREWDRIVER |
| Generic Name | SCREWDRIVERS |
| Product Code | HXX |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-02-14 |
| Model Number | 03.835.010 |
| Catalog Number | 03.835.010 |
| Lot Number | 9939889 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-25 |