MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LOOPED SUTURE WHT/BL COBRD STR NDLE 12PK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	IPN914069
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during acl procedure, external to patient, two sutures broke when the assistant was suturing the graft.Both sutures got detached from the needle when suturing.The procedure was successfully completed without delay using a s+n back-up device.No further complications were reported.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.Smith and nephew is the distributor of this device.The legal manufacturer will review the event and determine reportability and, if applicable, will report to the food and drug administration and any other authorities as deemed necessary.

• Brand Name: LOOPED SUTURE WHT/BL COBRD STR NDLE 12PK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12774415
• Report Number: 1219602-2021-02450
• Device Sequence Number: 5271822
• Product Code: MBI
• UDI-Device Identifier: 34026704637530
• UDI-Public: 34026704637530
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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: 02/19/2026
• Device Model Number: IPN914069
• Device Catalogue Number: 72205181
• Device Lot Number: 74B2101894
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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