MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-01-18 for ARTHRO SUTURE GRASPER *EA 214575 manufactured by Depuy Mitek Llc Us.
[133513169]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). The complaint device was received and evaluated. Visual observation reveals that the device is worn and showed heavy use. The laser marking on the device is slightly faded so no lot information was gathered. When the trigger was actuated to test for its functionality, the jaws did not open, thus confirming the complaint. Upon inspection of the device? S handle, it was found that the link between the handle and the actuator was worn and broken. This failure can be confirmed and can be attributed to field wear. A batch record review was not conducted as the specific lot number was unable to be determined from the complaint device. At this point in time, no corrective action is required and no further action is warranted. However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Patient Sequence No: 1, Text Type: N, H10
[133513170]
It was reported that during a demonstration in a cadaver lab, it was observed that the arthro suture grasper *ea broke. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-51848 |
| MDR Report Key | 8260218 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-18 |
| Date of Report | 2016-04-25 |
| Date Mfgr Received | 2016-04-25 |
| Date Added to Maude | 2019-01-18 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6013142063 |
| Manufacturer G1 | DEPUY MITEK LLC US |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTHRO SUTURE GRASPER *EA |
| Generic Name | SUTURE/NEEDLE PASSER, REUSABLE |
| Product Code | HCF |
| Date Received | 2019-01-18 |
| Returned To Mfg | 2016-05-13 |
| Catalog Number | 214575 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-18 |