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

Catalog Number 3910-500-752

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/18/2014

Event Type  Injury  

Event Description

The sales rep, (b)(6), has reported on behalf of their customer that a suture slider tip has allegedly been broken inside the joint of a pt.The sales rep has reported that the surgery was delayed for one hour.The sales rep has reported that they have given the tip away to product manager (b)(6) and also returned all of the other products that the customer had in stock.

• Brand Name: CHAMPION SUTURE SLIDERS
• Type of Device: PASSER
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS, CORP. LTD; kibbutz gaaton 2513 0; IS 25130
• MDR Report Key: 4217379
• MDR Text Key: 5073597
• Report Number: 2249697-2014-00008
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3910-500-752
• Device Lot Number: 318022813J05WV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2014
• Distributor Facility Aware Date: 09/18/2014
• Device Age: 1 YR
• Date Report to Manufacturer: 10/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other