MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-12-16 for WIRE FX BOLT SLOTTED SS 818050006 manufactured by Depuy Warsaw.
[2370350]
The two pieces are stuck together.
Patient Sequence No: 1, Text Type: D, B5
[9563862]
This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed.
Patient Sequence No: 1, Text Type: N, H10
[16926310]
Examination of the returned products confirmed the complaint. The cause is attributed to the suppliers manufacturing process, the major diameter of the bolt threads is oversized up to. 004, preventing the nut from fastening to the bolt. The thread form is sharp at the crest, compared to conforming bolts. Hold order (b)(4) was initiated on (b)(4) 2011. An hhe was conducted and is documented on (b)(4), eco# (b)(4). The lot numbers affected were recalled, root causes and corrective actions are captured in capa (b)(4) that was initiated on (b)(4) 2011. Depuy considers the investigation closed. Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2011-25227 |
| MDR Report Key | 2380075 |
| Report Source | 05,08 |
| Date Received | 2011-12-16 |
| Date of Report | 2011-11-30 |
| Date Mfgr Received | 2011-11-30 |
| Date Added to Maude | 2011-12-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHERINE SEPPA |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer G1 | DEPUY WARSAW |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WIRE FX BOLT SLOTTED SS |
| Generic Name | TRAUMA FIXATION |
| Product Code | HXK |
| Date Received | 2011-12-16 |
| Catalog Number | 818050006 |
| Lot Number | 582520 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY WARSAW |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-16 |