MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-08-17 for PROFIX 71512452 manufactured by Smith & Nephew, Inc., Orthopaedic Div.
[674108]
It was reported that the mallet broke during surgery, which left debris in the surgical field. Surgery was extended 30-40 minutes while the debris was removed.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1020279-2007-00190 |
MDR Report Key | 898364 |
Report Source | 07 |
Date Received | 2007-08-17 |
Date of Report | 2007-08-17 |
Date of Event | 2007-07-06 |
Date Mfgr Received | 2007-07-17 |
Date Added to Maude | 2007-08-22 |
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 | MS. LINDSAY CUMMINGS, SPECIALIST II |
Manufacturer Street | 1450 BROOKS RD. |
Manufacturer City | MEMPHIS TN 38116 |
Manufacturer Country | US |
Manufacturer Postal | 38116 |
Manufacturer Phone | 9013995946 |
Manufacturer G1 | SMITH & NEPHEW, INC. |
Manufacturer Street | 1450 BROOKS RD. |
Manufacturer City | MEMPHIS TN 38116 |
Manufacturer Country | US |
Manufacturer Postal Code | 38116 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PROFIX |
Generic Name | MALLET |
Product Code | HXL |
Date Received | 2007-08-17 |
Model Number | NA |
Catalog Number | 71512452 |
Lot Number | UNK |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 875769 |
Manufacturer | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV |
Manufacturer Address | 1450 BROOKS RD. MEMPHIS TN 38116 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2007-08-17 |