MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN SUTUREFIX ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	UNKNOWN
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, due to bone quality, when the 1.9mm suture fix anchor was placed in the glenoid, it came out.The procedure was finished using a 2.8mm q-fix suture anchor as a back up device.There was a surgical delay of less than 30 minutes and no further complications were reported.
Event or Problem Description
It was reported that during an arthroscopy, due to bone quality, when the 1.9mm suture fix anchor was placed in the glenoid, it came out.Thus, it was decided to place a 2.8mm q-fix suture anchor.The q-fix suture anchor was placed but never deployed.All the devices were removed from the patient, and the procedure was finished with a smith and nephew back-up device used in the originally drilled bone hole.There was a surgical delay of less than 30 minutes and no further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, instruction for use review, risk management review, could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A clinical review states that based on the limited information provided the clinical root cause of the reported events cannot be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.H11: corrected information in h6 (health effect - impact code).
Additional Manufacturer Narrative
H2: corrected data on: h6 (impact code).

• Brand Name: UNKNOWN SUTUREFIX ANCHOR
• 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: 18980569
• Report Number: 1219602-2024-00621
• Device Sequence Number: 15110614
• Product Code: MBI
• UDI-Device Identifier: 00885556686300
• UDI-Public: 885556686300
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K122059
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/16/2024

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 04/23/2024; 08/14/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/11/2024; 04/26/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female