MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION LOOK; 3/0 CHROMIC GUT 27" C6

Model Number	560B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records for the reported finished good lot and raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.The actual devices were not returned for review.No photos of the devices were available for review.If actual samples or photos become available, they will be reviewed and the results will be included in the file.A revised response will be forwarded to you at that time.The retained sample from the device history record was visually reviewed and tested.No defects or abnormalities were observed on the suture, needle, attachment or the package.The device met specification including the needle pull and tensile requirements for a 3-0 chromic gut suture/needle device.The suture size used to manufacture the reported lot was 3-0.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 during use.The needles detaching during use can occur due to the misalignment of the suture within the end of the needle, the suture material not placed deep enough within the end of the needle and/or if end is not crimped with enough force to form a secure grip onto the suture material.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 component.Chromic gut suture material can change color, become brittle; break easily if exposed more than the recommended time for this type of material.Surgical specialties documents the exposure time throughout the inspection and manufacturing processes to prevent over-exposure prior to packaging the devices.The exposure time for the reported lots were reviewed and met all current criteria.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 ¿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.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 reviewing the actual reported device(s)/packages, receiving magnified photos of the actual devices/packages, receiving sterile device(s) from the same lot to review/test, or receiving detailed information regarding the shipping, handling and storage of the device(s), exposure time prior to use, preoperative preparation of the devices, tools utilized to grasp the devices, or the surgeon''s technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
The needle is pulling apart from the suture, and it seems to happen most when it is being pulled through tissue.We have not taken photos as on one or more occasions, the needle needed to be emergently suctioned for retrieval.No injuries to report as we are judicious in our practice and use precautions like throat packs.

• Brand Name: LOOK
• Common Device Name: 3/0 CHROMIC GUT 27" C6
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b, ejido franciso villa; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 1100 berkshire blvd.; ste 308; reading PA 19608
• Manufacturer Contact: kelly knappenberger ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana baja california 22235 ; MX 22235
• MDR Report Key: 16425576
• Report Number: 3010692967-2023-00008
• Device Sequence Number: 5659946
• Product Code: GAL
• UDI-Device Identifier: 10848782009210
• UDI-Public: (01)10848782009210(17)270811(10)C912DYJ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2023
• Report Date (Section F): 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 560B
• Device Catalogue Number: 560B
• Device Lot Number: C912DYJ
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2023
• Device Age: 4 MO
• Event Location: Other
• Date Report to Manufacturer: 01/30/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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