MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN SUSPENSORY FIXATION DEVICE; RETENTION DEVICE, SUTURE

Catalog Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on the literature review "tensioning device increases coracoid bone block healing rates in arthroscopic latarjet procedure with suture-button fixation;" 1 patient had a traumatic recurrent shoulder instability at a mean of 7 months (range, 5-12 months) after an arthroscopic latarjet procedure where a suture button and tensioning device were used (mechanically tensioned).The patient outcome is unknown, and no further information is available.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
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 could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.Insufficient product identification information was provided and thus a complaint history review could not be conducted.Insufficient product identification information was provided and thus an instruction for use review could not be conducted.Insufficient product identification information was provided and thus a risk management review could not be conducted.A clinical review states that the images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The clinical root cause and/or patient outcome beyond that which was documented in the literature article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
Additional Manufacturer Narrative
Corrected information in d1 (brand name).

• Brand Name: UNKNOWN SUSPENSORY FIXATION DEVICE
• Common Device Name: RETENTION DEVICE, SUTURE
• 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: 16139840
• Report Number: 1219602-2023-00078
• Device Sequence Number: 6309696
• Product Code: KGS
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Supplement Date Received by Manufacturer: 03/27/2023; 04/26/2023
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 03/28/2023; 05/02/2023
• 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; Required Intervention
• Patient Sex: Unknown