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 2019-01-29 for IDEAL SUTURE SHUTTLE 45 DEGREES LEFT 251003 manufactured by Depuy Mitek Llc Us.
[134352021]
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). The exp date is currently unavailable. 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. 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. A device history record (dhr) 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. 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
[134352022]
It was reported by the affiliate in (b)(6) that during arthroscopic bankert repair the kite ofn the ideal suture shuttle 45 degrees left device broke just after beginning of the use. It was brand new and the first use when the issue occurred. The device was discarded at the hospital. There was no surgical delay or harm to the patient. The backup device was used to complete the case. 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 | 1221934-2018-51868 |
| MDR Report Key | 8284781 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-29 |
| Date of Report | 2016-07-06 |
| Date of Event | 2016-06-30 |
| Date Mfgr Received | 2019-01-31 |
| Device Manufacturer Date | 2019-03-01 |
| 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 |
| 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 45 DEGREES LEFT |
| Generic Name | SUTURE/NEEDLE PASSER, SINGLE-USE |
| Product Code | HCF |
| Date Received | 2019-01-29 |
| Catalog Number | 251003 |
| Lot Number | 15C03 |
| 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 | 2019-01-29 |