MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2007-05-22 for GII EASY ANCHOR W/ ETHIBOND EXCEL (CP-2 NEEDLE) 212450 manufactured by Depuy Mitek.
[17443121]
Our affiliate is reporting that after undergoing a rotator cuff repair performed in 2007, the patient phoned the surgeon eight days later, saying that he/she had temperature and pain in his/her operative shoulder. The patient was treated with an arthroscopic antibiotics washing. To date, the patient's health status is unknown. (see also associated reports 1221934-2007-00125 and 1221934-2007-00126).
Patient Sequence No: 1, Text Type: D, B5
[17679430]
Depuy mitek to date has not yet received the complaint device for evaluation. The actual complaint device is not being returned, only a sample device from the same lot. A batch record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the mitek complaints system revealed no other complaints of any kind for this lot of 215 devices that were released to distribution. At this time, we are still in the information-gathering phase. A mitek device was involved in a patient infection incident; therefore, we are filing a report to document this event. When and if more information is received that is both pertinent and germane to this issue, that information will be evaluated and the conclusions will be reflected in a follow up report. Similarly, when and if the complaint device is received here at depuy mitek, it will be subjected to a failure root cause analysis. If the analysis identifies any definitive root cause, a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2007-00124 |
| MDR Report Key | 853603 |
| Report Source | 01,05,06,07 |
| Date Received | 2007-05-22 |
| Date of Report | 2007-05-22 |
| Date of Event | 2007-03-29 |
| Report Date | 2007-05-22 |
| Date Mfgr Received | 2007-05-02 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2007-05-30 |
| 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 | DANIELLE DUFOUR |
| Manufacturer Street | 325 PARAMOUNT DR. |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088283674 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GII EASY ANCHOR W/ ETHIBOND EXCEL (CP-2 NEEDLE) |
| Generic Name | SOFT TISSUE FIXATION DEVICE |
| Product Code | NOV |
| Date Received | 2007-05-22 |
| Model Number | 212450 |
| Catalog Number | 212450 |
| Lot Number | 2911144 |
| ID Number | NA |
| Device Expiration Date | 2011-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 840682 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | RAYNHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-05-22 |