MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION LOOK; LOOK CHROMIC GUT, 4-0, 18" C6, 3/8 CIRCLE 19MM

Model Number	558B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Needle detached twice.First incident the needle remained grasped with the hemostat and removed/discarded.No injury or intervention.Second event the needle could not be located.The dentist performed a chest x-ray but no needle was found.The office was searched, needle not found.The dentist thought needle may have been sucked up by the high volume suction.No patient injury reported.
Additional Manufacturer Narrative
A review of the device history records confirmed there were no quality issues noted throughout the incoming inspection of raw material components, manufacturing, in-process or final inspection processes.No samples were provided for review or testing.No retained samples were available for review.If sterile samples from this lot or photographs become available at a later time, the devices and/or photos will be reviewed and/or tested and the results will be included in the file.A revised report will be submitted at that time.The suture size used to manufacture the reported lot was 4-0.Usp size 7-0 is the only size gut suture that is packaged dry.Usp size 6-0 through 4 gut sutures are packaged in a wetting solution and should be utilized promptly upon removing from the foil package.If these devices are opened, removed from the foil package and left exposed, the alcohol solution will evaporate, allowing the sutures to become dry, brittle and possibly break or detach during use.Natural absorbable sutures, like the products in this report, have a tendency to fray during knot construction.Additionally, there is considerably more variability in the retention of tensile strength than is found with other types of sutures.The needle detaching from the suture during use most likely resulted from the interaction of specific procedural related stress in contrast to the strength of the attachment.It''s also possible the devices are being grasped on or near the swaged end of the needle, damaging the suture, allowing the suture to break free from the needle.The ¿precautions¿ section in the ifu for the device states, ¿care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments such as needle holders and forceps.The surgeon should avoid unnecessary tension when running down knots, to reduce the occurrence of surface fraying and weakening of the strand.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 the actual devices/packages for review, magnified photos of the devices/packages at the time of event or receiving details regarding the shipping, storage and handling of the devices, exposure time prior to use (are devices being utilized promptly upon opening to avoid the drying of the alcohol solution; drying of the suture material), preoperative preparation of the device(s) or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

• Brand Name: LOOK
• Common Device Name: LOOK CHROMIC GUT, 4-0, 18" C6, 3/8 CIRCLE 19MM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 12849601
• Report Number: 3010692967-2021-00051
• Device Sequence Number: 14586153
• Product Code: GAL
• UDI-Device Identifier: 10848782009197
• UDI-Public: (01)10848782009197(17)240327(10)AADZ924
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K896554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/19/2021
• Report Date (Section F): 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: 558B
• Device Catalogue Number: 558B
• Device Lot Number: AADZ924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2021
• Device Age: 31 MO
• Event Location: Other
• Date Report to Manufacturer: 10/26/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown