MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-18 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[134193149]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). The exp date is currently unavailable. The complaint device was received and evaluated. Visual observation of the device reveals the tip of the pusher rod was bent upwards and the distal part of the rod was bent significantly downwards. This is possibly due to forced loading/unloading of the needle. There was no damage to the loading rod. The pusher and loading rods were covered with stains; indicating that they were used. The damage to tip of the main pusher rod could potentially cause the second implant to deploy before the first implant and cause misfiring. Other than this possibility, a definitive root cause cannot be determined at this point from the details provided. The needle associated with this incident was not available at the time of investigation. A batch record 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 internally assignable cause for the reported problem. Further, a review into the depuy synthes mitek complaints system revealed dissimilar complaint for this lot released to distribution. At this point in time, 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. A non-conformance search was performed for this product code 228143, lot 3906348 combination and no non-conformances were identified. No further information regarding the technique or instruments used has been provided to determine a root cause for this failure. If any additional information is obtained, this complaint will be re-opened to capture that information. At this point in time, no corrective action is required, and no further action is warranted. 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
[134193150]
This is report 2 of 2 for the same event. It was reported by the sales rep that during an anterior cruciate ligament reconstruction acl/meniscus repair surgical procedure, it was observed that the second anchor would start to deploy when using the customer's ominspan meniscal repair 12 degree and the customer's meniscal deployment gun before the first implant would deploy. The sales rep reported that the surgeon completed the procedure with other likes devices with no patient consequences but there was a five minute delay. The sales rep stated that they are unsure if the gun is at fault or the implants. 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 | 1221934-2019-56048 |
| MDR Report Key | 8261923 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-18 |
| Date of Report | 2016-07-25 |
| Date of Event | 2016-07-25 |
| Date Mfgr Received | 2016-07-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2019-01-18 |
| Returned To Mfg | 2016-08-10 |
| Catalog Number | 228143 |
| Lot Number | 3906348 |
| 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 |