MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN SUSPENSORY FIXATION DEV; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Rupture (2208)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Paper name: medium-term (least 5 years) comparative outcomes in anterior cruciate ligament reconstruction using 4shg, allograft, and lars ligament http://dx.Doi.Org/10.1097/jsm.0000000000000730.

Event Description

It was reported that on literature review "medium-term (least 5 years) comparative outcomes in anterior cruciate ligament reconstruction using 4shg, allograft, and lars ligament"; 1 patient had a graft re-rupture diagnosed 5 years after an anterior cruciate ligament procedure using an endobutton and a bioabsorbable interference screw.The broken graft was separately replaced in a revision surgery.The patient's outcome is unknown.No further information is available.

Manufacturer Narrative

H10: 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 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.Insufficient product identification information was provided, and thus, a product print specification review could not be conducted.A clinical review states the images, charts, or graphs documented/referenced in the article (per the author/writer) have been interpreted within the text.Therefore, further interpretation of the provided images is not required 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.

• Brand Name: UNKN SUSPENSORY FIXATION DEV
• Type of Device: 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: 16043125
• MDR Text Key: 306085564
• Report Number: 1219602-2022-02030
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other