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 Lelocle.
[2397344]
The wire fixation nut will not screw onto offset wire fixation bolt.
Patient Sequence No: 1, Text Type: D, B5
[9572221]
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
[9825141]
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), (b)(4). The lot numbers affected were recalled, root causes and corrective actions are captured in (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
[21032246]
The devices associated with this report were not returned. A search of the complaint database found no additional reports for the reported head part and lot code combination; two prior reports for the metal insert part and lot code combination. However, review of the as400 system show that 14 other devices from the reported metal insert lot have been delivered and/or invoiced and can be reasonably concluded implanted without issue. Review of the device history records found no related manufacturing deviations or related anomalies. The investigation could not verify or identify any product contribution to the reported event with the information provided. Based on the inability to determine a root cause, the need for corrective action was not indicated. 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 | 1818910-2011-25226 |
| MDR Report Key | 2380074 |
| 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 LELOCLE |
| Manufacturer Street | RUE GIRARDET 29 CASE POSTALE |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| 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 LELOCLE |
| Manufacturer Address | RUE GIRARDET 29 CASE POSTALE LE LOCLE SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-16 |