MAUDE Adverse Event Report: T.A.G. MEDICAL PRODUCTS CORP. LTD CHAMPION SUTURE SLIDER; PASSER

Catalog Number 3910-500-751

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 04/02/2014

Event Type  Injury  

Event Description

Doctor was using champion slider to take bite of labrum to pass the suture through and broke part of the slider needle off in the joint.He then tried to locate the broken piece and remove it from inside the joint but was unable to.It remained in the pt.Surgery was prolonged for approximately 30-60min.The broken part of the device was left inside the pt's joint.Surgeon stated that he will most likely have to go back in for another surgery at a later date to remove it.

• Brand Name: CHAMPION SUTURE SLIDER
• Type of Device: PASSER
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS CORP. LTD; kibbutz gaaton ; IS
• MDR Report Key: 3855851
• MDR Text Key: 4618397
• Report Number: 2249697-2014-00007
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: 3910-500-751
• Device Lot Number: 13F76
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/29/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2014
• Distributor Facility Aware Date: 04/02/2014
• Device Age: 1 YR
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR