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 2019-01-18 for LONG COMPRESSION DEVICE FOR TI CANNULATED TIBIAL NAILS-EX 03.010.137 manufactured by Wrights Lane Synthes Usa Products Llc.
[133861174]
Device is expected to be returned for manufacturer review/investigation, but has not been received yet. Product was not returned. Device history records review could not be completed without lot number. Based on the information available, it has been determined that no corrective and 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
[133861175]
It was reported that on (b)(6) 2018, before the surgery on titanium cannulated tibial nails expert nailing system, the scrub technician opened the tibial nail expert set. It was noticed that the cannulated connecting screw had the long compression device mechanism incarcerated within the screw. They could separate the two. They used another connecting screw. Patient was not in the room when it was noticed. There was no surgical delay. The procedure was successfully completed. There was no patient consequence. This report is for one (1) compression device. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-55955 |
| MDR Report Key | 8262320 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-18 |
| Date of Report | 2018-12-28 |
| Date Mfgr Received | 2019-02-11 |
| Device Manufacturer Date | 2013-12-12 |
| Date Added to Maude | 2019-01-18 |
| 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 WRIGHT 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 | LONG COMPRESSION DEVICE FOR TI CANNULATED TIBIAL NAILS-EX |
| Generic Name | INSTRUMENT COMPRESSION |
| Product Code | HWN |
| Date Received | 2019-01-18 |
| Returned To Mfg | 2019-01-14 |
| Catalog Number | 03.010.137 |
| Lot Number | T994932 |
| 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 | 2019-01-18 |