MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-10 for IDEAL SUTURE SHUTTLE 45 DEGREES LEFT 251003 manufactured by Depuy Mitek Llc Us.
[123506267]
(b)(4). The complaint device is not available for physical evaluation, hence, the complaint cannot be confirmed. 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. Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices with the product code that were released to distribution. No further information regarding the technique used has been provided to determine a root cause for this failure. If any additional information is obtained, this complaint will be re-opened to capture that information. At this point in time, no corrective and preventative action is required and no further action is warranted. 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.
Patient Sequence No: 1, Text Type: N, H10
[123506268]
This is the second device involved in report 1221934-2018-50701. . It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that when the surgeon went to pull the chia wire back, it would not pull through, got stuck and broke. A second chia wire was tried and it occurred again. It was reported that an additional suture shuttle was opened to complete the surgery. It was not reported if there was a delay in the procedure. There was patient involvement reported. There were no injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown but was noted to have occurred in 2018. 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 | 1221934-2018-54919 |
| MDR Report Key | 7952846 |
| Date Received | 2018-10-10 |
| Date of Report | 2018-04-25 |
| Date of Event | 2018-01-01 |
| Date Mfgr Received | 2018-04-25 |
| Device Manufacturer Date | 2017-11-22 |
| Date Added to Maude | 2018-10-10 |
| 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. JENNIFER LAWRENCE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| 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 | 0 |
| Brand Name | IDEAL SUTURE SHUTTLE 45 DEGREES LEFT |
| Generic Name | SUTURE/NEEDLE PASSER, SINGLE-USE |
| Product Code | HCF |
| Date Received | 2018-10-10 |
| Catalog Number | 251003 |
| Lot Number | 17P08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-10-10 |