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 2019-01-18 for IDEAL SUTURE SHUTTLE 25 DEGREES RIGHT -G 251002 manufactured by Depuy Mitek Llc Us.
[134194805]
If additional information should become available, a supplemental medwatch will be submitted accordingly. Udi: (b)(4). The exp date is currently unavailable. 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 one similar complaint for this lot of (b)(4) 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 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. 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
[134194806]
It was reported by the sales rep that during a shoulder labral procedure when removing the customer's ideal suture shuttle 25 degree right, the ideal suture shuttle 25 degrees right -g device broke on the distal tip. The sales rep stated that the device broke outside the patient. The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences but there was a five minute delay. The sales rep stated that the device was discarded. 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 | 1221934-2018-52072 |
| MDR Report Key | 8261054 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-18 |
| Date of Report | 2016-06-27 |
| Date of Event | 2016-06-27 |
| Date Mfgr Received | 2016-06-27 |
| Device Manufacturer Date | 2015-09-20 |
| Date Added to Maude | 2019-01-18 |
| 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 RIGHT -G |
| Generic Name | SUTURE/NEEDLE PASSER, SINGLE-USE |
| Product Code | HCF |
| Date Received | 2019-01-18 |
| Catalog Number | 251002 |
| Lot Number | 15M01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2019-01-18 |