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 ROTATOR CUFF EASY ANCHOR W/ #2 PANACRYL 212315 manufactured by Depuy Mitek.
[644341]
Our affiliate is reporting that two days after undergoing an arthroscopic capsuloplastic performed in 2007, the patient started suffering from an infection in his/her shoulder that caused temperature, pain, increased inflammation, and had inflammatory hematochemical parameters. The patient underwent a second arthroscopic surgery 21 days later, that revealed articular sepsis. The surgeon performed an arthroscopic antibiotics washing. The patient is now fine, no more infection symptoms persist and esr and c protein values returned to normal range. (see also associated mdrs 1221934-2007-00121 and 1221934-2007-00122).
Patient Sequence No: 1, Text Type: D, B5
[7871717]
The complaint device is not being returned, therefore is unavailable for a physical evaluation. 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 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. However, 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221934-2007-00120 |
| MDR Report Key | 853606 |
| Report Source | 01,05,06,07 |
| Date Received | 2007-05-22 |
| Date of Report | 2007-05-21 |
| Date of Event | 2007-03-28 |
| Report Date | 2007-05-21 |
| Date Mfgr Received | 2007-05-02 |
| Device Manufacturer Date | 2006-10-01 |
| 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 | ROTATOR CUFF EASY ANCHOR W/ #2 PANACRYL |
| Generic Name | SOFT TISSUE FIXATION DEVICE |
| Product Code | NOV |
| Date Received | 2007-05-22 |
| Model Number | 212315 |
| Catalog Number | 212315 |
| Lot Number | 2963122 |
| ID Number | NA |
| Device Expiration Date | 2011-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 840711 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | RAYNHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-05-22 |