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 2019-01-28 for IDEAL SUTRE SHUTLE STRGHT CRESCENT -G 251007 manufactured by Depuy Mitek Llc Us.
[136253289]
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 review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution. We cannot discern a root cause for the reported failure mode. 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. 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 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
[136253290]
This is report 2 of 3 for the same event. It was reported by the affiliate in (b)(6) that during a labral repair surgical procedure, it was observed that the nitinol wire broke when pulling the ideal suture shuttle 45 degrees left tape through. It was reported that this happened on three ideal suture shuttle 45 degrees left devices. According to the reporter, the surgeon was pulling gently but the devices still broke. The surgeon opened three extra shuttles to complete the procedure with a 15 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 | 1221934-2018-53464 |
| MDR Report Key | 8282232 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-28 |
| Date of Report | 2017-02-14 |
| Date of Event | 2017-02-14 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2016-05-01 |
| Date Added to Maude | 2019-01-28 |
| 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 | IDEAL SUTRE SHUTLE STRGHT CRESCENT -G |
| Generic Name | SUTURE/NEEDLE PASSER, SINGLE-USE |
| Product Code | HCF |
| Date Received | 2019-01-28 |
| Catalog Number | 251007 |
| Lot Number | 16E16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-01-28 |