MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION HENRY SCHEIN; HS 3-0 PGA UNDYED BR 18"/45CM PC31

Model Number 900-4421

Device Problem Break (1069)

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

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

-method: the actual product involved with the incident was discarded.No samples were returned for evaluation to date.-results/conclusions: no samples were returned for review.Relevant portions of the device history record were reviewed.The product from this finished good lot and all of the component lots met current (b)(4).Requirements throughout the incoming, manufacturing and the final inspection processes.No inventory is available for the finished good lot reported.-without receiving samples to review/test, receiving detailed information regarding the pre-operative preparation of the device or the surgeon's technique, a definitive root cause for the needle breaking during use cannot be determined at this time.Reference:reference (b)(4).- henry schein reference #(b)(4).- item #900-4421 henry schein 3-0 pga undyd br 18"/45cm pc31 , lot mbcq750.

Event Description

It was reported by the customer that the needle broke during a cyst excision on the neck.An xray was required to locate the needle segment retained in the wound.The piece was removed without injury or further incident.

• Brand Name: HENRY SCHEIN
• Type of Device: HS 3-0 PGA UNDYED BR 18"/45CM PC31
• 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: 6991470
• MDR Text Key: 91229787
• Report Number: 3010692967-2017-00012
• Device Sequence Number: 1
• Product Code: GAB
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/29/2021
• Device Model Number: 900-4421
• Device Catalogue Number: 900-4421
• Device Lot Number: MBCQ750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2016
• 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