MAUDE Adverse Event Report: SURGICAL SPECIALTIES PUERTO RICO, INC. STRATAFIX; SPIRAL UNI PDO

Model Number SXPD1B401

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

To date no samples have been returned for evaluation.A batch review of the finished goods lot reported was performed.No non-conformances reports were issued for the finished goods lot.The product from this finished goods lot and all of the components met surgical specialties requirements throughout the incoming, manufacturing and the final inspection processes.The fracturing / breaking of a needle can often occur when needles are gripped with a needle holder/forceps at the swaged area and/or near the tip of the device.The stress at the gripped area may exceed the maximum stress of the material resulting in bending and/or failure (broken needle).The stress on the attachment section is greatly reduced when the needle is held in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point as indicated in the ifu for this product.Without reviewing the actual broken device, testing devices from the same finished good lot or receiving details regarding the pre-operative preparation of the device or the surgeon¿s technique a definitive root cause cannot be determined at this time.The ¿precautions¿ section in the ifu for this product states, ¿care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments such as needle holders and forceps.The surgeon should avoid unnecessary tension when running down knots, to reduce the occurrence of surface fraying and weakening of the strand.¿ to avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point.

Event Description

Needles breakage.The patient is female, (b)(6) and no medical disease history.The patient had a laparoscopic myomectomy operation under general anesthesia on (b)(6) 2018.During sewing the two-centimeter diameter myoma of the anterior wall of the uterus, the needle broke after the third stitch.The breakage position is about 0.5-1 cm away from the needle tail.Retrieved the broken piece and changed another needle to sew 10-centimeter diameter myoma of the posterior wall of the uterus, the needle broke during the second stitch, the broken piece fell into the uterus, the breakage position is similar as the first one which is about 0.5-1 cm away from the needle tail.It took around 30 minutes~1 hour to look for the broken needle piece and finally was retrieved.Changed another one to complete the surgery.Now the patient is in stable status.

• Brand Name: STRATAFIX
• Type of Device: SPIRAL UNI PDO
• Manufacturer (Section D): SURGICAL SPECIALTIES PUERTO RICO, INC.; rd.459 montana industrial park; aquadila PR 00605
• Manufacturer Contact: ronald giannangelo ; 247 station drive; suite ne1; westwood, MA 02090
• MDR Report Key: 7833073
• MDR Text Key: 119045432
• Report Number: 3010692967-2018-00017
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,08/30/2018

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: 07/31/2022
• Device Model Number: SXPD1B401
• Device Lot Number: MDWC960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 07/31/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2018
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR