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 2019-01-25 for MENISCAL DEPLOYMENT GUN 228143 manufactured by Depuy Mitek Llc Us.
[135197971]
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: a review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4). This report is being filed from the (b)(4) 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
[135197972]
It was reported by the sales rep that during meniscal repair surgical procedure, it was observed that when the customer pulled the needle out of their meniscal deployment gun to put another needle in, a spring came out and they were unable to put another needle in. The case was completed with another like device. There were no patient consequences or delays. The sales rep was not present during the case and could not provide any more details. 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 | 1221934-2018-55447 |
| MDR Report Key | 8278989 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-25 |
| Date of Report | 2017-07-21 |
| Date of Event | 2017-07-21 |
| Date Mfgr Received | 2017-07-21 |
| Device Manufacturer Date | 2015-08-31 |
| 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 |
| 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 | 2019-01-25 |
| Catalog Number | 228143 |
| Lot Number | NI |
| Device Expiration Date | 2018-05-31 |
| 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 |