MAUDE Adverse Event Report: DEPUY MITEK DOUBLE ARM MENISCAL NDLS W/2-0 OC; MITEK SUTURE

Catalog Number 228144

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 01/08/2015

Event Type  Injury  

Event Description

The nurse from ethicon reported that a patient who underwent a back surgery called in to her, as she is experiencing pain and sharp bumps on her back in the same area as the operation (muscles reattached) up and down her back.The nurse did not have the age of the patient or how long after the surgery she started to experience pain/sharp bumps.It is unknown to the nurse where she had the surgery; however, the patient has had two prior surgeries.The first surgery the sutures were coming out of the skin so they had to be removed and the second surgery there were no issues.The nurse also indicated that prior to this surgery the patient has had skin tests for allergies with the orthocord and the area became red but no actual reaction.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.

Manufacturer Narrative

The complaint device is not being returned, therefore unavailable for a physical evaluation.It appears that the orthocord was used in a spine procedure, but this cannot be confirmed.Orthocord suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.The nurse has tried to get more information from the patient but the patient refused to provide any additional information.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.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.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.

Event Description

The nurse from ethicon reported that a patient who underwent a back surgery called in to her, as she is experiencing pain and sharp bumps on her back in the same area as the operation( muscles reattached) up and down her back.The nurse did not have the age of the patient or how long after the surgery she started to experience pain/sharp bumps.It is unknown to the nurse where she had the surgery; however, the patient has had two prior surgeries.The first surgery the sutures were coming out of the skin so they had to be removed and the second surgery there were no issues.The nurse also indicated that prior to this surgery the patient has had skin tests for allergies with the orthocord and the area became red but no actual reaction.

• Brand Name: DOUBLE ARM MENISCAL NDLS W/2-0 OC
• Type of Device: MITEK SUTURE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: bahaa nashed ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4767156
• MDR Text Key: 16861513
• Report Number: 1221934-2015-00777
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 228144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/08/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2015
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention