MAUDE Adverse Event Report: BONE TUNNEL PLUG LARGE 10-11MM; ACCESSORIES,ARTHROSCOPIC

Model Number	013562
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the surgery red dye was coming off the lettering at the end of the plug continually as powder.Smith and nephew back-up device was available to complete the surgery.No delay was reported.No other complications 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.There was a relationship found between the subject device and the reported incident.A review of the customer-supplied photograph was performed and observed red coloration smear around the lettering.The complaint was confirmed.Factors, unrelated to the manufacturing and design of the device which could have contributed to the reported event, include cleaning and sterilization.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of the instructions for use found certain sterilization and maintenance techniques are required, a review of risk management files found that the reported failure was documented appropriately.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H10: h3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A complaint history review concluded this was a repeat issue.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and 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 risk management files found that the reported failure was documented appropriately.A review of the customer-supplied photograph was performed and observed red coloration smear around the lettering.A visual inspection found a red stain around the markings on the top of the bone plug.A review of the complaint revealed there were no patient injuries reported and no apparent patient impact based on the details provided.Therefore, no further medical assessment is warranted.The complaint was confirmed.Factors that could have contributed to the reported event include inappropriate cleaning and sterilization methods.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.No containment or corrective actions are recommended at this time.

• Brand Name: BONE TUNNEL PLUG LARGE 10-11MM
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• MDR Report Key: 10624299
• Report Number: 1219602-2020-01513
• Device Sequence Number: 16907716
• Product Code: NBH
• UDI-Device Identifier: 03596010091147
• UDI-Public: 03596010091147
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 11/04/2021

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 Model Number: 013562
• Device Catalogue Number: 013562
• Device Lot Number: 50809452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 03/26/2021; 11/02/2021
• Initial Report FDA Received Date: 10/03/2020
• Supplement Report FDA Received Date: 03/27/2021; 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention