MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72200148
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a dislocation of the right acromioclavicular using an endobutton, the wound was found oozing and not healing.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One 72200148 endobutton ultra 25mm continuous loop reported on.The product was used for treatment but was not returned for evaluation.Due to unavailability, evaluation was limited.If further information becomes available to assist with evaluation, the complaint may be revisited.Factors affecting device performance include, device ability, surgical ability and surgical site preparation according to instructions for use.Instructions for use shipped with or available for the product code reported, has instructions for use available, which includes recommendations, instructions and precautionary statements for proper use of the product.Complaint history review indicated no similar allegations for the lot number reported.Batch review did not indicate a condition or product, procedure failure that supported the allegation.Sterilization documentation indicated the lot as sterile.Product met specifications upon release to distribution.At this time, there is no objective evidence to suggest a direct link between the product used during the procedure and the post-operative condition reported.Rate of occurrence is monitored via surveillance.No further investigation required at this time.

• Brand Name: ENDOBUTTON CL ULTRA 25MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9575117
• Report Number: 1219602-2020-00064
• Device Sequence Number: 16904806
• Product Code: MBI
• UDI-Device Identifier: 03596010597274
• UDI-Public: 03596010597274
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K980155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2023
• Device Model Number: 72200148
• Device Catalogue Number: 72200148
• Device Lot Number: 50772640
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR