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

Catalog Number UNKNOWN

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that after ac joint reconstruction where an endobutton was used, intraosseous migration was noted in one patient.Patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10.H3, h6: part number and lot number were not provided.Product was not available.Due to unavailability, evaluation was limited.If further information becomes available the complaint may be revisited.At this time, there is no objective evidence to suggest a direct link between the post-operative condition and product used during the procedure.There was also no evidence to suggest that product from this family did not pass requirements upon release for use.Complaint history review was unattainable without a valid lot number and product code provided.Batch review was unattainable without a valid lot number provided.The risk management documentation was reviewed and found to contain this failure mode within the risk file for this device family.There is no identifying patient information or supporting relevant clinical documentation provided.Therefore, a clinical assessment is unable to be performed at this time.No further actions required at this time.

• Brand Name: ENDOBUTTON
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9744038
• MDR Text Key: 182044426
• Report Number: 1219602-2020-00367
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• PMA/PMN Number: K980155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1