MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GRFTMSTR EBTN HLDR; TEMPLATE

Model Number	014415
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the scaling on the endo button holder is drawn in incorrectly.The malfunction happened before the procedure and was solved with a delay shorter than 30 minutes.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported endobutton holder, used in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, the scaling on the endo button holder is drawn in incorrectly.An exact root cause cannot be determined with confidence without the return of the device.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported device, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.

• Brand Name: GRFTMSTR EBTN HLDR
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10286473
• Report Number: 1219602-2020-01069
• Device Sequence Number: 10911848
• Product Code: HWT
• UDI-Device Identifier: 03596010397362
• UDI-Public: 03596010397362
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 014415
• Device Catalogue Number: 014415
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR