MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for SPEED COMPRESSION IMPLANT KIT 11X10X10MM SE-1110 manufactured by Wrights Lane Synthes Usa Products Llc.
[186758406]
The event date is unknown in 2020. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; 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
[186758407]
It was reported that on an unknown date, neither of the two (2) speed compression plate, one (1) speed compression implant sizing guide, one (1) speed drill kit after they were deployed from the inserter the legs stayed straight and did not compress at all. There was no surgical delay. The procedure was successfully completed. There was no patient consequence. Concomitant device reported: unknown insertion (part # unknown, lot # unknown, quantity # 1). This complaint involves two (2) devices. This is 1 of 2 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01418 |
| MDR Report Key | 9861412 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-22 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-22 |
| Date Added to Maude | 2020-03-20 |
| 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 11X10X10MM |
| Generic Name | BONE STAPLE |
| Product Code | JDR |
| Date Received | 2020-03-20 |
| Model Number | SE-1110 |
| Catalog Number | SE-1110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-20 |