MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for SPEED COMPRESSION IMPLANT KIT 20X15X15MM SE-2015 manufactured by Wrights Lane Synthes Usa Products Llc.
[185908519]
(b)(6). The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. 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
[185908520]
It was reported that on an unknown date, while restocking the sterile implant tote, it was noticed that the staple was deployed from the handle in the package. This renders the device unusable. There was no patient involvement. This report involves one (1) speed compression implant kit 20x15x15mm. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01618 |
| MDR Report Key | 9904336 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2017-08-16 |
| Date Added to Maude | 2020-03-31 |
| 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 | 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 BME : SAN ANTONIO |
| Manufacturer Street | 14785 OMICRON DRIVE #205 |
| Manufacturer City | SAN ANTONIO TX 78245 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78245 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPEED COMPRESSION IMPLANT KIT 20X15X15MM |
| Generic Name | BONE STAPLE |
| Product Code | JDR |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-16 |
| Model Number | SE-2015 |
| Catalog Number | SE-2015 |
| Lot Number | BSE170537 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-31 |