MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2010-04-09 for PINN CAN BONE SCREW 6.5MMX20MM 121720500 manufactured by Depuy-raynham, A Div Of Depuy Orthopaedics, Inc..
[1580965]
Patient was revised to remove a 6. 5mm acetabular screw that was too long for the hole chosen in cup.
Patient Sequence No: 1, Text Type: D, B5
[8544833]
The device associated with this report was not returned. A complaint database search finds no other reported incidents against the provided product and lot combination since its release for distribution. The investigation could not draw any conclusions regarding the reported event. Based on the inability to determine a root cause, the need for corrective action was not indicated. Depuy considers the investigation closed at this time. Should the product and/or 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 | 1818910-2010-01900 |
| MDR Report Key | 1657448 |
| Report Source | 05,08 |
| Date Received | 2010-04-09 |
| Date of Report | 2010-03-10 |
| Date of Event | 2010-03-10 |
| Date Mfgr Received | 2010-03-10 |
| Device Manufacturer Date | 2009-12-01 |
| Date Added to Maude | 2010-04-15 |
| 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, MGR. |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 5743727333 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | WARSAW IN 02767035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 0350 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PINN CAN BONE SCREW 6.5MMX20MM |
| Generic Name | 87NJD; 87LPH |
| Product Code | NJD |
| Date Received | 2010-04-09 |
| Model Number | NA |
| Catalog Number | 121720500 |
| Lot Number | 418164 |
| ID Number | NA |
| 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-RAYNHAM, A DIV OF DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA 02767035 US 02767 0350 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-09 |