MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION LOOK; LOOK C17 6-0 BLACK MONO NYL 18"/45CM

Model Number 916B

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

-method: the actual product involved with the incident was discarded.Sterile samples from the same finished good lot were returned for evaluation.-results/conclusions: all samples were visually reviewed and ductility/bend tested and met current requirements for this size/type needle/suture 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 (b)(4).Requirements throughout the incoming, manufacturing and the final inspection processes.No inventory is available for the finished good lot reported.-without receiving the actual broken device 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.

Event Description

It was reported by the end user that the needle broke while suturing a chin laceration.An x-ray was required to locate the needle segment retained in the wound.The piece was removed without injury or further incident.

• Brand Name: LOOK
• Type of Device: LOOK C17 6-0 BLACK MONO NYL 18"/45CM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000; 24702-b, ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: kelly knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 6990909
• MDR Text Key: 91923012
• Report Number: 3010692967-2017-00010
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903029
• 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: 02/02/2017,02/28/2017

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: 916B
• Device Catalogue Number: 916B
• Device Lot Number: MBGY030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/31/2017
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2017
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• 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
• Patient Age: 17 YR