MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-17 for ARTHREX AR406845LRH manufactured by Medline Renewal.
[170105944]
It was reported that during an unidentified procedure, the tip of the reprocessed arthrex suturelasso? Sd, 45 degree, curve left, w/nitinol wire loop, (blue), broke off into the patient. It was added that additional anesthesia was administered to the patient as a result of the incident. General anesthesia was used and there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident. No information was provided whether the tip was retrieved from the patient or what medical intervention was required to retrieve the device tip that broke off into the patient. There was no serious injury or adverse patient consequence reported related to this event. Due to the reported issue of the device tip breaking off into the patient, this medwatch is being filed. The sample was returned for evaluation and the issue was confirmed. Upon inspection of the received device, it was confirmed that the tip had broken off. The broken piece was not returned for evaluation. A review of the device history record (dhr) was performed. The review indicated that all processes were conducted as required at the time the lot was processed. A definitive root cause for the reported issue could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[170105945]
It was reported that the tip of the reprocessed arthrex suturelasso? Sd broke off into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032391-2019-00024 |
| MDR Report Key | 9202510 |
| Date Received | 2019-10-17 |
| Date of Report | 2019-10-17 |
| Date of Event | 2019-10-08 |
| Date Mfgr Received | 2019-10-09 |
| Device Manufacturer Date | 2019-07-12 |
| Date Added to Maude | 2019-10-17 |
| 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 | STEPHEN WILSON |
| Manufacturer Street | 1500 NE HEMLOCK AVE |
| Manufacturer City | REDMOND OR 97756 |
| Manufacturer Country | US |
| Manufacturer Postal | 97756 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARTHREX |
| Generic Name | SUTURELASSO? SD, 45 DEGREE, CURVE LEFT, W/NITINOL WIRE LOOP, (BLUE) |
| Product Code | HWQ |
| Date Received | 2019-10-17 |
| Returned To Mfg | 2019-10-16 |
| Catalog Number | AR406845LRH |
| Lot Number | 418867 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE RENEWAL |
| Manufacturer Address | 1500 NE HEMLOCK AVE REDMOND OR 97756 US 97756 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-10-17 |