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 Injury (2348)

Event Type  Injury  

Event Description

It was reported that after the coracoclavicular reconstruction technique using 3 endobutton cl, the endobutton under the coracoid slipped into the drill hole in the coracoid, which resulted in a loss of the anatomical reduction that had been confirmed on radiographs of the involved ac joint on the third postoperative day.Two days later, a second operation was performed to correct the displacement of the endobutton and reduce the ac joint.At the 12 months follow-up, there no infections or other complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

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, however a review of the risk management, labeling and instructions for use documentation was reviewed for this device family and found to contain statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the complaint records was also 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.This complaint was reported from the literature review.During the studying it was reported that three days following the procedure, the endobutton under the coracoid slipped into the drill hole in the coracoid, which resulted in a loss of the anatomical reduction that had been confirmed on radiographs of the involved ac joint.Two days later, a second operation was performed to correct the displacement of the endobutton and reduce the ac joint.At the 12 months follow-up, there were no infections or other complications reported.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.Should information become available this complaint can 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: 9745124
• MDR Text Key: 180569935
• Report Number: 1219602-2020-00378
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other