MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-01-18 for ARTHRO SUTURE SCISSORS *EA 214605 manufactured by Depuy Mitek Llc Us.
[134587815]
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). The complaint device was received and evaluated. Visual observation revealed that the distal tip was slightly bent and the device looked worn with scratches. A test suture was tested with the device and the device failed to cut the suture cleanly. Upon further investigation, the blade appeared dull. The root cause can be attributed to normal wear and tear of the device form normal use and sterilization. Further, a review into the mitek complaints system revealed no other complaints for this serial number that was released to distribution. At this point, no corrective action is required and no further action is warranted. A device history 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; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. 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 (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
[134587816]
It was reported by the sales rep that during a shoulder/rotator cuff surgical procedure, it was observed that the top jaw of the customer's suture scissors would not work and when trying to fix it the top piece of the device broke off. The sales rep stated that the device did not break in the patient. The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences but there was a minute delay. The sales rep was not present for the case therefore could not provide any further information. The sales rep stated that only the handle part will be returning for evaluation and that the top piece 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 | 1221934-2018-52114 |
| MDR Report Key | 8261309 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-18 |
| Date of Report | 2016-08-01 |
| Date of Event | 2016-07-28 |
| Date Mfgr Received | 2016-08-01 |
| Device Manufacturer Date | 2004-11-10 |
| 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 | ARTHRO SUTURE SCISSORS *EA |
| Generic Name | SUTURE CUTTER |
| Product Code | FZT |
| Date Received | 2019-01-18 |
| Returned To Mfg | 2016-09-16 |
| Catalog Number | 214605 |
| Lot Number | 4J2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-01-18 |