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  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that after an acl reconstruction, the patient had a migration of the endobutton after 3 to 12 months of surgery.The migration of the device did not affect clinical outcomes.The 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: during the studying it was reported after an acl reconstruction, the patient had a migration of the endobutton 3 to 12 months after the surgery.The migration of the device did not affect clinical outcomes.The patient outcome is unknown.After three requests no individual clinical information has been provided for inclusion in this medical investigation.Without supporting clinical/medical documents, a thorough investigation cannot be performed.In addition, the physician referenced in the abstract provided an analysis of all of the attached x-rays.Therefore, no further interpretation of the attached x-rays are required.Should information become available this complaint can be re-assessed.Part number and lot number were not provided.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 allegation reported and product used during the procedure.Instruction for use for the product family contains precautionary statements and recommendations for proper use.In addition, there was no evidence to suggest that product did not pass requirements upon release for use.Complaint history review for three years prior indicated similar allegations for the product family reported.Batch review was unattainable without a valid lot number provided.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: 9743059
• MDR Text Key: 181541205
• Report Number: 1219602-2020-00365
• 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: foreign,literature,other,user
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

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: 02/23/2020
• Supplement Dates Manufacturer Received: 04/10/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1