MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION STRATAFIX; STRATAFIX SXPD2B412 2/0 PDO

Model Number SXPD2B412

Device Problems Bent (1059); Break (1069); Material Integrity Problem (2978)

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

Event Date 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for testing or review.The device history and manufacturing records for this particular lot were reviewed.No quality issues were noted throughout the incoming inspection of raw materials, manufacturing processes, in-process or final inspections.There were no other complaints received for this finished good lot.The surgeon stated that when the needles are utilized on tough skin or are grasped at the back of the needle, they sometime bend or break off during use.The ¿precautions¿ section in the ifu for this product states, ¿care should be taken to avoid damage when handling.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." without receiving samples to review/test it is not known of the exact location the device was grasped or where the break occurred.A definitive root cause could not be determined at this time.

Event Description

During a bilateral knee procedure; the suture needle broke when closing right knee; unable to find needle on first wound exploration.Flat plate obtained, located needle, removed needle.Another flat plate x-ray obtained.No further needle seen, and final count correct with broken needle matching up.It is not known how the procedure was completed.There were no adverse patient consequences reported.Device is not available for return.Orthopedic surgeon stated, ¿it was the number zero stratafix needle.Sometimes with tough skin the needles will bend when they are held in the normal position near the back of the needle as you pass it through.This one bent a few times and broke off within the skin layers on a subsequent pass.I don¿t necessarily think it was defective, but i think they could make the needles stronger.¿.

• Brand Name: STRATAFIX
• Type of Device: STRATAFIX SXPD2B412 2/0 PDO
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000; 24702-b, ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: kelly knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 6955947
• MDR Text Key: 90545825
• Report Number: 3010692967-2017-00005
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: SXPD2B412
• Device Catalogue Number: SXPD2B412
• Device Lot Number: MBJW370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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
• Patient Outcome(s): Required Intervention