MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-22 for SMART PIN * 121540 manufactured by Conmed Linvatec Biomaterials Ltd.
[20157605]
A report of smart pin which split during insertion. The pin was removed. The procedure (left 2nd hammertoe procedure) was finished with other smart pins. Procedure: 2nd left hammertoe. He reports he was using a 5/64 k-wire (1. 984mm) to drill for the 1. 5mm pins. He reports he has been using bioabsorbable pins for 17 years and our product for 3 years without any prior problems. He also reports he does not use the applicator to impact the pin. He reports he cuts off the excess of the pin and then uses a hemostat to push/insert the pin in as he is overdrilling the hole with the k-wire. He reports he has been doing this for 3 years also.
Patient Sequence No: 1, Text Type: D, B5
[20550908]
The device has not yet been properly investigated/evaluated. A follow-up report will be created after evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613278-2007-00008 |
| MDR Report Key | 839399 |
| Date Received | 2007-02-22 |
| Date of Report | 2007-01-10 |
| Date of Event | 2007-01-10 |
| Date Mfgr Received | 2007-01-10 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2007-04-21 |
| 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 | 0 |
| Manufacturer Contact | JOHANNA EINTOLA |
| Manufacturer Street | HERMIANKATU 6-8 L |
| Manufacturer City | TAMPERE FI-33720 |
| Manufacturer Country | FI |
| Manufacturer Postal | FI-33720 |
| Manufacturer Phone | 505291574 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART PIN |
| Generic Name | BIOABSORBABLE BONE FIXATION DEVICE |
| Product Code | MBJ |
| Date Received | 2007-02-22 |
| Returned To Mfg | 2007-01-25 |
| Model Number | * |
| Catalog Number | 121540 |
| Lot Number | S0002575 |
| ID Number | * |
| Device Expiration Date | 2011-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 826692 |
| Manufacturer | CONMED LINVATEC BIOMATERIALS LTD |
| Manufacturer Address | * TAMPERE FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-22 |