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 2020-03-13 for UNK - CABLE/WIRE manufactured by Wrights Lane Synthes Usa Products Llc.
[188843802]
This report is for an unknown cable/wire/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or 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
[188843843]
It was reported that on an unknown date during an unknown procedure the cable tensioner got stuck on the unknown cable. The unknown cable was tensioned, crimped and cut without any problems. When removing the unknown cable from the cable tensioner, the unknown cable was stuck inside and prevented the surgeon from tensioning another cable. The unknown cable was unable to be removed. The surgeon had to open another set and cut the cable and used a different cable tensioner. The procedure was completed successfully. There was a surgical delay of four (4) minutes. There was no complication with the patient. This report is for one unknown cable/wire. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01259 |
| MDR Report Key | 9829921 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-17 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-03-13 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - CABLE/WIRE |
| Generic Name | WIRE, SURGICAL |
| Product Code | LRN |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2020-03-13 |