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 2019-01-15 for IDEAL SUTURE SHUTTLE 45 DEGREES LEFT 251003 manufactured by Depuy Mitek Llc Us.
[134071499]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4) - incomplete. The lot number is currently unavailable; therefore, the exp date is unavailable. The complaint device is not available for a physical evaluation and therefore a root cause for this failure cannot be discerned. Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system. At this point in time, no further action is warranted. However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed. 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
[134071500]
This is report 3 of 3 for the same event. It was reported by the affiliate in (b)(6) that during shoulder stabilization surgical procedure, it was observed that the suture shuttle kite broke, then another one was opened. According to the reporter, the tip of the bioknotless anchor broke off in the joint space of the patient. It was further reported that when the second bioknotless anchor was used, the inserter bent at the join of the shoulder. The tip of the inserter then broke off in the patient as it was being pulled out. The one centimeter metal piece of the anchor got stuck in the joint space of the patient and the surgeon was unable to retrieve it. The surgeon had to change from an arthroscopic surgery to an open surgery, and worked for one to two hours in order to remove the metal piece. The object was eventually removed with another surgeon assistance. There was a 180 minute delay to surgery. It was reported that the patient outcome post surgery was suboptimal. 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 | 1221934-2018-51120 |
| MDR Report Key | 8248104 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-15 |
| Date of Report | 2016-01-14 |
| Date of Event | 2016-01-14 |
| Date Mfgr Received | 2016-01-14 |
| Date Added to Maude | 2019-01-15 |
| 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 | 2019-01-15 |
| Catalog Number | 251003 |
| Lot Number | UNK |
| 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 | 2019-01-15 |