MAUDE Adverse Event Report: T.A.G. MEDICAL PRODUCTS, CORP, LTD. CHAMPION SLIDER NEEDLE; NONE

Model Number 3910-500-751

Device Problems Activation, Positioning or Separation Problem (2906); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

Physician 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 patient.The surgery was prolonged for approximately 30-60min.The surgeon stated he will most likely have to go back in for another surgery at a later date to remove the broken part.

Manufacturer Narrative

Dhr records were verified and no discrepancy was recorded on these items.Raw materials inspection records with no discrepancy.(b)(4).Concentricity of 1mm hole was found within spec.No other defects were detected.According to the attached image the fracture was caused due to wrong bending conditions and extensive external load.This device intended to be used on soft tissue as stated in the ifu.In the report it is stated that device was used on labrum and that the surgeon likely struck bone.This device is not designed to be in use on bones.See the following in the ifu 505st - paragraph indication and precautions.This product use is passing suture tissue during minimally invasive surgery.Do not apply excessive axial or bending force to the slider needle during use, as excessive force may limit the function of the device or cause the device to bend, deform or break.

• Brand Name: CHAMPION SLIDER NEEDLE
• Type of Device: NONE
• Manufacturer (Section D): T.A.G. MEDICAL PRODUCTS, CORP, LTD.; kibbutz gaaton; 2513 0; IS 25130
• Manufacturer Contact: george hattub, us agent and oc ; kibbutz gaaton; IS 25130 ; 4796116
• MDR Report Key: 3896245
• MDR Text Key: 4545458
• Report Number: 8043971-2014-00001
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3910-500-751
• Device Lot Number: 13F76
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR