MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 15MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72200146
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a the ligament repair surgery, when tightening the suture loop of the endobutton, the bone hole was damage, it break.The procedure was successfully completed with non-significant delay by changing the surgical technique using biosure device fixations of both ends.Patient status is reported to be good and no further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was received for evaluation.There was no relationship found between the device and the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection of the returned device found that it is not in its original packaging.The green suture string is knotted at the proximal end.The loop has debris in the strands.Both suture strings were retuned installed on the device.The provided photo was reviewed.Further patient impact beyond that which has already been reported cannot be determined.However it has been reported that the patient¿s current status is good.No further medical assessment is warranted at this time.The complaint was not confirmed, and the root cause could not be determined.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force or an impact event inconsistent with normal use.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: ENDOBUTTON CL ULTRA 15MM
• 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: 15996564
• Report Number: 1219602-2022-01988
• Device Sequence Number: 17622932
• Product Code: MBI
• UDI-Device Identifier: 03596010597250
• UDI-Public: 03596010597250
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 06/19/2026
• Device Model Number: 72200146
• Device Catalogue Number: 72200146
• Device Lot Number: 2075557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2021
• 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: Other
• Patient Sex: Unknown