MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-23 for ERGO UNK 321-52-06 manufactured by Exactech, Inc..
[189079365]
Pending evaluation. Concomitant device(s): cannulated reamers, 315-52-63, modular cannulated center peg drill.
Patient Sequence No: 1, Text Type: N, H10
[189079366]
As reported, the cannulated reamers and center drill gets stuck on the kwire. Threaded k-wire for new ergo instruments broke at the end of the threaded part. Piece broke off in the glenoid when removing the pin. Part of the threaded piece was removed and part of it was left in patient. Patient was discharged home without complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1038671-2020-00013 |
| MDR Report Key | 9621803 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-23 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-05-23 |
| Date Mfgr Received | 2020-01-26 |
| Date Added to Maude | 2020-01-23 |
| 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 | KATE JACOBSON |
| Manufacturer Phone | 3523771140 |
| Manufacturer G1 | EXACTECH, INC. |
| Manufacturer Street | 2320 NW 66 CT |
| Manufacturer City | GAINESVILLE FL 32653 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32653 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0168-2020 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ERGO |
| Generic Name | 3.2MM THREADED K-WIRE STERILE |
| Product Code | KWT |
| Date Received | 2020-01-23 |
| Model Number | UNK |
| Catalog Number | 321-52-06 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXACTECH, INC. |
| Manufacturer Address | 2320 NW 66 COURT GAINESVILLE FL 32653 US 32653 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-23 |