MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION HENRY SCHEIN; 4-0 BLACK MONO NYLON C-3 REV CUTTING NEEDLE

Model Number 900-7466

Device Problem Break (1069)

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

Event Date 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

Method: the actual broken device was discarded by the end user.Sterile product from the reported lot were returned for review/testing on 4/1/2017.-results/conclusions: the sterile devices were bend/ductility tested per current criteria and met all requirements for this size/type needle device.Relevant portions of the device history record were reviewed.The product from this finished good lot and all of the component lots met current usp and surgical specialties (b)(4).Requirements throughout the incoming, manufacturing and the final inspection processes.Without receiving detailed information regarding the pre-operative preparation of the device, actual procedure, or the surgeon's technique a definitive root cause for the needle breaking during the procedure cannot be determined with certainty.

Event Description

It was reported by the customer that the needle broke while closing a wound on the back.An x-ray was required to locate the needle segment retained in the wound.The segment was removed with radiologic guidance without further incident.No injuries were reported.

• Brand Name: HENRY SCHEIN
• Type of Device: 4-0 BLACK MONO NYLON C-3 REV CUTTING NEEDLE
• 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: 6990893
• MDR Text Key: 91918729
• Report Number: 3010692967-2017-00008
• 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,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2017,04/07/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2021
• Device Model Number: 900-7466
• Device Catalogue Number: 900-7466
• Device Lot Number: AAAG767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/06/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2017
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62