MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-01-29 for RAPIDLOC PDS/PLA 2/0 PAN 12 228311 manufactured by Depuy Mitek Llc Us.
[134340836]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. P/n: 228311. The complaint device was not returned, therefore unavailable for a physical evaluation. Furthermore, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system. At this point in time, no corrective action is required and no further action is warranted. This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue. 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 (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[134340837]
It was reported that during a meniscus repair the customers meniscal applier kept jamming. The deployment spring kept sticking when the trigger was pulled. To complete the case the surgeon opened a new meniscal applier and a new needle. There were no patient consequences or delays. This is report 2 of 2.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56195 |
| MDR Report Key | 8284667 |
| Report Source | OTHER |
| Date Received | 2019-01-29 |
| Date of Report | 2016-10-06 |
| Date of Event | 2016-10-06 |
| Date Mfgr Received | 2016-10-06 |
| Date Added to Maude | 2019-01-29 |
| 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 | MRS. KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089776860 |
| Manufacturer G1 | DEPUY MITEK |
| 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 | RAPIDLOC PDS/PLA 2/0 PAN 12 |
| Generic Name | ORTHOPAEDIC CERCLAGE APPLIER |
| Product Code | GEF |
| Date Received | 2019-01-29 |
| Catalog Number | 228311 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-01-29 |