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 2019-01-22 for IDEAL SUTURE SHUTTLE 25 DEGREES LEFT -G 251001 manufactured by Depuy Mitek Llc Us.
[134629086]
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. We cannot discern a root cause for the reported failure mode. A review into the depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that were released to distribution. At this point in time, no corrective action is required and no further action is warranted. A device history 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; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed 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
[134629087]
It was reported by the sales rep that the customer's ideal suture shuttle 25 degree left failed during a labrum repair surgical procedure due to the tip being dented then it cracked during the procedure and the surgeon did not think it would withstand another pass. According to the reporter, the angled shaft cracked during the procedure. Once he removed it from the joint he felt as though it cracked and would not withstand another pass. The case was completed with another like device. There were no adverse patient consequences or time delays reported. The device will not be returned as the facility discarded it. 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 | 1221934-2018-53064 |
| MDR Report Key | 8268930 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-22 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-12-13 |
| Date Mfgr Received | 2016-12-13 |
| Date Added to Maude | 2019-01-22 |
| 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 | IDEAL SUTURE SHUTTLE 25 DEGREES LEFT -G |
| Generic Name | SUTURE/NEEDLE PASSER, SINGLE-USE |
| Product Code | HCF |
| Date Received | 2019-01-22 |
| Catalog Number | 251001 |
| Lot Number | 15J05 |
| 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 | 2019-01-22 |