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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Joint Dislocation (2374); Malunion of Bone (4529)

Event Date 06/30/2016

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that on literature review "coracoid bone block fixation with cortical buttons: an alternative to screw fixation?", 2 patients had recurrent instability due to dislocation, after an arthroscopic bone block procedure using a double endobutton device.These patients presented nonunion of the bone block.It is unknown how the event was treated.No further information is available.

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the device and the reported event.Insufficient product identification information was provided and thus a complaint history review could not be performed.Insufficient product identification information was provided and thus a manufacturing record review could not be performed.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.Insufficient product identification information was provided, and thus, an instructions for use review could not be conducted.Insufficient product identification information was provided, and thus, a risk management review could not be conducted.Based on a review of this complaint, as of the date of this medical investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The patient impact beyond that which was reported cannot be determined and the patient¿s current health status is unknown.Therefore, no further clinical/medical assessment can be rendered.Should any additional clinical information be provided, this complaint may be re-evaluated.The complaint was not confirmed.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 DOUBLE ENDOBUTTON 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: 15413410
• MDR Text Key: 299812886
• Report Number: 1219602-2022-01373
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K980155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/06/2022
• 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