MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA, 15MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72200146
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374); No Code Available (3191)
Date of Event	07/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient initials: (b)(6).
Event or Problem Description
It was reported that after use the device to fix for acromioclavicular joint reduction purpose as the patient had an acromioclavicular joint third-degree dislocation.It was found that the endobutton lost its fixation, so the patient had to accept a second surgery.
Additional Manufacturer Narrative
Due to no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.If relevant information becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: ENDOBUTTON CL ULTRA, 15MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7084555
• Report Number: 1219602-2017-01511
• Device Sequence Number: 1297984
• Product Code: MBI
• UDI-Device Identifier: 03596010597250
• UDI-Public: (01)03596010597250(17)200806(10)50560197
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2020
• Device Model Number: 72200146
• Device Catalogue Number: 72200146
• Device Lot Number: 50560197
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR