MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION LOOK; PLAIN GUT 19MM REV CUTTING NEEDLE/SUTURE

Model Number 554B

Device Problem Break (1069)

Patient Problems Pain (1994); Swelling (2091)

Event Date 04/27/2017

Event Type  Injury  

Manufacturer Narrative

-method: the actual device was discarded.Sterile devices from the same lot were returned for testing and visual examination.-results/conclusions: 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) inc.Requirements throughout the incoming, manufacturing and the final inspection processes.The returned sterile samples from the same finished good lot were ductility tested and visually reviewed.All devices met the current requirements for this size/type needle/suture device.-without reviewing the actual device to determine tool placement, 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 with certainty.

Event Description

While attempting to place a dental implant in site #19 under iv sedation, the patient had a challenging airway.To correct the situation, the surgeon attempted to place a tongue traction suture to improve the airway.The needle fractured and was retained in the tongue.After unsuccessfully trying to retrieve it in the office, the patient was taken to hospital or, placed under general anesthesia via a nasal endotracheal tube.Once patient was asleep, paralyzed and airway under control, the needle segment was located and removed by enlarging previous incision.The needle was removed without further incident or injury to the patient.The patient will be re-evaluated when sutures are removed.Adverse sequelae reported:pain, swelling, decreased function of the tongue and delay in initial treatment.The incision may leave a possible scar and may decrease sensation in the area distal from to the incision that was required to remove the fragment.

• Brand Name: LOOK
• Type of Device: PLAIN GUT 19MM REV CUTTING NEEDLE/SUTURE
• 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: 7004407
• MDR Text Key: 91152096
• Report Number: 3010692967-2017-00013
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896554
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2021
• Device Model Number: 554B
• Device Catalogue Number: 554B
• Device Lot Number: AAAR758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/27/2017
• Device Age: 3 MO
• Event Location: Examination Room
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• 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: 55 YR