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

Model Number SXPD1B400

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

"during laparoscopic uterine myomectomy, the uterus was sutured with stratafix.The scrub tech noted that the tip of one of the stratafix ct-1 needles was missing.Attempts to locate it were unsuccessful and a postoperative abdominal x-ray was performed, which revealed no radiopaque foreign body.(b)(4).

Manufacturer Narrative

The actual product involved with the incident reported will not be returned.Method: the actual product involved with the incident reported will not be returned.Results/conclusions: the actual product involved with the incident reported will not be returned.Relevant portions of the device history record were reviewed.Finished good product was received into inventory without quality issues.The product from this finished good lot and all of the components met surgical specialties puerto rico inc requirements throughout the incoming, mfg and the final inspection processes.No inventory available for the finished good lot reported.Needle supplier which is our customer as well was contacted to verify if there were any quality issues related to these needle batches.Supplier confirmed that no ncr's were generated as part of the mfg process of the needle lot.The needle supplier has been made aware of this complaint for a continued investigation.Per add'l email communication received on (b)(6) 2014, attempts to locate the tip of the needle were unsuccessful and a postoperative abdominal x-ray was performed, which revealed no radiopaque foreign body.(b)(4).Item #sxpd1b400 stratafix spiral pdo knotless tissue control device.Ct-1 0 pdo 20cm, lot mbys210.

• 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, sr. qa mgr ; road 459 km 0.6; montana industrial park; aguadilla, PR 00603 ; 7876581800
• MDR Report Key: 3949006
• MDR Text Key: 4644533
• Report Number: 3008845715-2014-00013
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113744
• 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: 05/02/2014

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 Expiration Date: 07/31/2016
• Device Model Number: SXPD1B400
• Device Catalogue Number: SXPD1B400
• Device Lot Number: MBYS210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/18/2014
• Initial Date FDA Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• 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.