MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO QUILL; 2DE11 3-0 PDO 7 X 7

Model Number RA-1017Q

Device Problem Device Fell (4014)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record for the finished good devices and the components confirmed there were no quality issues noted throughout the incoming inspection, manufacturing, in-process or final inspection processes.No samples were returned by the end user.No retained samples were available for testing/review.Needles detaching from the suture most likely resulted from the interaction of specific procedural related stress in contrast to the strength of the suture/needle attachment.It is also possible that the devices are being gripped on or near the attachment causing damage to the swaged end of the needle component or snipping the suture which causes the suture to break/snap away from the needle.However, there are numerous other circumstances that can adversely affect the strength and durability of a suture/needle attachment including but not limited to the misalignment of the suture within the end of the needle, the suture material not placed deep enough within the end of the needle and/or if the swaged end is not crimped with enough force to form a secure grip onto the suture material.A definitive root cause is most times very difficult to determine without reviewing the actual failed devices or receiving detailed information regarding the pre-operative preparation of the devices, tools utilized to grasp the device(s) or the surgeon's technique.

Event Description

The needle detached from the suture device during a jejunostomy operation, when the suture was fixed on the abdominal wall.The needle was suspected to have fallen into the abdominal cavity.The first-time intraperitoneal exploration failed.After several c-arm fluoroscopy probe searches, the needle was located in the abdominal wall.An incision was made and the needle was found in the muscle layer and removed which took approximately 3 hours.No patient injury was reported.

• Brand Name: QUILL
• Type of Device: 2DE11 3-0 PDO 7 X 7
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO; corredor 2000 tij-rosarito no.; 24702 -b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES MEXICO; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: kelly knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 9439596
• MDR Text Key: 207426021
• Report Number: 3010692967-2019-00039
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: RA-1017Q
• Device Catalogue Number: RA-1017Q
• Device Lot Number: AABE161
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 10/16/2019
• Device Age: 53 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2019
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR