MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-23 for ACUTE AC REPAIR KIT AR-2271 manufactured by Arthrex, Inc..
[145973912]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. Attempts to receive additional information have received no response. The root cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[145973913]
It was reported by the hospital that a patient experienced an infection after having arthrex parts implanted. At the time of the call the facility reporter was looking to obtain additional information regarding the implants, and did not have any other available information other than the arthrex parts that were used in the original procedure. The following arthrex parts were used during the original procedure: ar-2271 // lot: f185810 (acute ac repair kit), ar-7209t (tigerstick, #2 tigerwire), ar-2275 (obturator - instrument does not remain in patient). Update 5/23/19: several attempts have been made to obtain additional information with no response received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2019-01108 |
| MDR Report Key | 8636988 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-23 |
| Date of Report | 2019-06-06 |
| Date of Event | 2018-01-30 |
| Date Mfgr Received | 2019-05-01 |
| Device Manufacturer Date | 2018-01-19 |
| Date Added to Maude | 2019-05-23 |
| 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 | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACUTE AC REPAIR KIT |
| Generic Name | WASHER, BOLT NUT |
| Product Code | HTN |
| Date Received | 2019-05-23 |
| Model Number | ACUTE AC REPAIR KIT |
| Catalog Number | AR-2271 |
| Lot Number | F185810 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-23 |