MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-30 for IDEAL SUTURE SHUTTLE 45 DEGREES LEFT 251003 manufactured by Depuy Mitek Llc Us.
[134469691]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. The complaint device is not being returned, therefore is unavailable for a physical evaluation. A batch 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 and therefore there is no internally assignable cause for the reported problem. Further, a review into the depuy synthes mitek complaints system revealed 1 other similar complaint 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. 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 dhr review: part number: 251003; supplier lot number: 15c03; qty of lot: (b)(4) devices; release to warehouse date: 29th march 2015; manufacturing date: march 2015; expiration date: na; supplier: tag; manufacturing site: tag. Any anomalies or discrepancies in the manufacture of the lot: none. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[134469692]
It was reported that during surgery the tip of the device broke when the surgeon threaded the device. 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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2019-56249 |
| MDR Report Key | 8288504 |
| Date Received | 2019-01-30 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2016-08-05 |
| Device Manufacturer Date | 2015-03-29 |
| Date Added to Maude | 2019-01-30 |
| 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. KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089776860 |
| Manufacturer G1 | DEPUY MITEK |
| 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 | 2019-01-30 |
| Catalog Number | 251003 |
| Lot Number | 15C03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2019-01-30 |