MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KIT BICEPTOR DISPOSABLES 9MM X 15MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202301
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a proximal biceps tenodesis, an expired biceptor implant was implanted in the patient.It is unknown how the procedure was performed.No delays occurred.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10, h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.A review of the instructions for use found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of the manufacturing procedure found that carton label should contain the earliest expiration date of all three devices within package.A review of risk management files found that the reported failure was documented appropriately.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: KIT BICEPTOR DISPOSABLES 9MM X 15MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10558157
• Report Number: 1219602-2020-01439
• Device Sequence Number: 19531400
• Product Code: MBI
• UDI-Device Identifier: 03596010620859
• UDI-Public: 03596010620859
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 72202301
• Device Catalogue Number: 72202301
• Device Lot Number: 50558836
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 09/20/2020
• Supplement Report FDA Received Date: 05/19/2021
• 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; Required Intervention