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 2019-01-25 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[135530832]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). The complaint device is not being returned, therefore unavailable for a physical evaluation. A dhr 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 evidence of manufacturing anomalies on the paperwork reviewed. Further, a review into the depuy synthes mitek complaints system revealed one dissimilar complaint for this lot of devices that were released to distribution. We cannot determine what caused the user to experience the reported event, we cannot discern a root cause for the reported failure mode. At this point in time, no corrective action is required and no further action is warranted. However, depuy synthes 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
[135530833]
This is report 1 of 2 for the same event. It was reported by the affiliate in (b)(6) that during a meniscal repair surgical procedure, it was observed that the silicone sheath moved and the seam could not be placed after placing the omnispan repair system and inserting into the joint. According to the reporter, the needle was so tightly clamped that it was not possible to take it off. It was further reported that the applicator and needle were unfortunately disposed by cleaning forces; therefore, nothing was coming back. A same like product was used to complete the procedure with no harm to the patient but there was a 10 minute delay. 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 | 1221934-2018-53853 |
| MDR Report Key | 8278321 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-25 |
| Date of Report | 2017-07-11 |
| Date of Event | 2017-07-10 |
| Date Mfgr Received | 2017-07-11 |
| Date Added to Maude | 2019-01-25 |
| 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 | MENISCAL DEPLOYMENT GUN |
| Generic Name | ORTHOPAEDIC CERCLAGE APPLIER |
| Product Code | GEF |
| Date Received | 2019-01-25 |
| Catalog Number | 228143 |
| Lot Number | 3919798 |
| Device Expiration Date | 2019-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-01-25 |