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 acl reconstruction procedure, it was noted the endobutton migrated.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

H3, h6: evaluation is not possible, as the unknown endobutton device will not be returned.The part and lot number have not been provided making an examination of the manufacturing records prohibitive.A review of the complaint records was performed for this device family, which confirmed additional complaints have been reported within the scope of the reported study.The investigation was limited to the information provided.This investigation could not draw any conclusions about the reported event with the limited clinical details provided.If additional clinical details become available in the future, the investigation will be reopened.A review of the journal article provided reported after acl reconstruction procedure, the endobutton migrated.Patient outcome is unknown.However, without the requested patient specific clinical information a thorough medical investigation cannot be rendered.Additionally, the patient's current condition nor the impact to the patient be cannot be determined.Therefore, no further medical assessment can be rendered at this time.Should any additional medical information be provided this complaint would be re-assessed.

• 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: 9751285
• MDR Text Key: 182217362
• Report Number: 1219602-2020-00426
• 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: 03/30/2020

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: 02/25/2020
• Supplement Dates Manufacturer Received: 03/26/2020
• Supplement Dates FDA Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1