MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-16 for SELF CONSTRAINED AWL (STAINLESS STEEL) 61730 manufactured by Alphatec Spine Inc.
[93138928]
An evaluation of the returned device revealed a fragment of the distal tip had broken and detached from the instrument. The remainder of the pointed edges are slightly bent/deformed and no longer sharp. The manipulation appears to be consistent with that of possibly impacting/striking with excessive force at the proximal end of the instrument. The self constrained awl is designed to create a pilot hole through cortical bone by pushing down on the handle of the instrument.
Patient Sequence No: 1, Text Type: N, H10
[93138929]
An international customer ((b)(6)) reported that the tip of the awl is broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027467-2017-00083 |
| MDR Report Key | 7039007 |
| Date Received | 2017-11-16 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-10-23 |
| Date Mfgr Received | 2017-10-24 |
| Device Manufacturer Date | 2010-06-23 |
| Date Added to Maude | 2017-11-16 |
| 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 | MR. RICHARD YOUNGER |
| Manufacturer Street | 5818 EL CAMINO REAL |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer Phone | 7604946842 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SELF CONSTRAINED AWL (STAINLESS STEEL) |
| Generic Name | HWJ |
| Product Code | HWJ |
| Date Received | 2017-11-16 |
| Returned To Mfg | 2017-10-31 |
| Model Number | 61730 |
| Catalog Number | 61730 |
| Lot Number | 5873701 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALPHATEC SPINE INC |
| Manufacturer Address | 5818 EL CAMINO REAL CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-16 |