MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-31 for OMNISPAN MENISCAL APPLIER 228143 manufactured by Depuy Mitek Llc Us.
[119508756]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Evaluation statement: this failure mode was investigated upon receiving the returned applier and needle. Upon receipt of the device, the needle was on the applier with the sliding implant. Both triggers were tested for functionality. The applier was unable to advance (red trigger) or deploy (gray trigger) the sliding implant as was noted in the complaint, thus confirming the failure mode. The gray trigger was not under tension from the internal spring as would be typical with the main pusher rod jammed under the sliding implant. The sliding implant was unable to be moved utilizing the gray or red triggers, thus again confirming the jamming condition. It was also noted the sliding implant had moved from its original position and was located on the ramp, which is typical of a movement due to interaction with surrounding structures around the area of repair. While pulling out of the meniscus to prepare for the 2nd deployment, the meniscus or a surrounding structure caused the sliding implant to move down the ramp. These conditions could lead to the implant and pusher rod occupying the same space, thus causing the jamming condition. Therefore, the jamming condition can be attributed to use error in these conditions in the meniscus. A batch record review has been conducted and 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 similar complaints for this lot of devices that were released to distribution. 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. Udi: (b)(4). This report is being filed from the (b)(4) 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
[119508757]
This is report 1 of 2 for the same event. It was reported by the affiliate in (b)(6) that during meniscal repair surgical procedure, it was observed that the omnispan meniscal applier device did not work on the omnispan meniscal repair system, w/ 12 degree needle, ea while in use together. It was not reported if there were any delays in a surgical procedure or if a spare device was available. There was patient involvement reported. There were no injuries, medical intervention or prolonged hospitalization. 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 | 1221934-2018-54165 |
| MDR Report Key | 7837417 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-31 |
| Date of Report | 2014-07-25 |
| Date of Event | 2014-07-23 |
| Date Mfgr Received | 2014-07-25 |
| Device Manufacturer Date | 2012-06-04 |
| Date Added to Maude | 2018-08-31 |
| 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 | MRS. JENNIFER LAWRENCE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| 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 | OMNISPAN MENISCAL APPLIER |
| Generic Name | ORTHOPAEDIC CERCLAGE APPLIER |
| Product Code | GEF |
| Date Received | 2018-08-31 |
| Returned To Mfg | 2014-08-21 |
| Catalog Number | 228143 |
| Lot Number | 3620306 |
| Device Expiration Date | 2015-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-31 |