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 SMALL HEXAGONAL SCREWDRIVER SHAFT 314.03 manufactured by Wrights Lane Synthes Usa Products Llc.
[186752517]
Product complaint # (b)(4). Device returned. Reporter is a synthes rep. A review of the device history record. Device history lot part/lot (314. 03/2046)combination are unknown at synthes gmbh, no dhr review possible. Device history batch null, device history review a cursory inspection of the complaint file for the device that was found damaged does not point to a manufacturing issue. Therefore a dhr/mre is not required. Investigation summary: background: it was reported that during a routine incoming inspection of a loaner set at fsl owens & minor ashland, va site on an unknown date, a small hexagonal screwdriver shaft was bent. There were no patient and surgical involvement reported. This complaint involves one (1) device. Investigation flow: damage. Visual inspection: the small hexagonal screwdriver shaft (p/n 314. 030 lot 2046) was received showing the distal tip twisted, no longer holding a hex shape tip. No other issues were identified with the returned components of the device. The reported condition of bent can be confirmed. Conclusion: 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. 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
[186752518]
It was reported that during a routine incoming inspection of a loaner set at fsl owens & minor ashland, va site on an unknown date, a small hexagonal screwdriver shaft was bent. There were no patient and surgical involvement reported. This complaint involves one (1) device. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01526 |
| MDR Report Key | 9881127 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| 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 | WERK H |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMALL HEXAGONAL SCREWDRIVER SHAFT |
| Generic Name | SCREWDRIVERS |
| Product Code | HXX |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-02-26 |
| Model Number | 314.03 |
| Catalog Number | 314.03 |
| Lot Number | 2046 |
| 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 |