MAUDE Adverse Event Report: SURGICAL SPECIALTIES PUERTO RICO INC. STRATAFIX KNOTLESS TISSUE CONTROL DEVICE; BARBED MATERIAL/NEEDLES

Lot Number UNA

Device Problems Detachment Of Device Component (1104); Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

It was reported by the sales rep that during a myomectomy, the surgeon used an unk stratafix suture with a ct-1 needle.The scrub tech noted that after removing the suture from the body, the tip of the needle appeared to be missing.The staff estimated it was 1 to 2 mm of the ct-1 needle.The pt had an xray and the needle did not appear to be in the pt.Despite looking thru all the debris of the case they could not find the tip of the needle.The pt was told by the surgeon that the tip of the needle may be in pt.(b)(4).

Manufacturer Narrative

The actual product involved with the incident reported will not be returned.Method: the actual device call not be returned.Results/conclusions: the actual device will not be returned.No product eval can be performed.Without the finished good item/lot number it is not certain if there were any quality issues against the needle component or the finished good lot.(b)(4).Item number and finished good lot number - unk.

• Brand Name: STRATAFIX KNOTLESS TISSUE CONTROL DEVICE
• Type of Device: BARBED MATERIAL/NEEDLES
• Manufacturer (Section D): SURGICAL SPECIALTIES PUERTO RICO INC.; aguadilla PR
• Manufacturer Contact: marcia caro, manager ; road 459 km 0.6; montana industrial park; aguadilla, PR 00603 ; 7876581800
• MDR Report Key: 3879820
• MDR Text Key: 4568954
• Report Number: 3008845715-2014-00001
• Device Sequence Number: 1
• Product Code: NEW
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/03/2014
• Initial Date FDA Received: 02/11/2014
• 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
• Treatment: NONE MADE AVAILABLE
• Patient Outcome(s): Required Intervention