MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL ENDOBUTTON 4.5MM (ONST); INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	013184
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during acl procedure, doctor opened an endobutton cl pac and as the case went on and he used the 4.5mm drill tip he realized the 4.5 drill bit looked different than others he had used in the past.He asked to get another pac to compare the two, and they were different.The drill bit opened first, was larger and had a different tip than the second one.He ended up having to create another tunnel with the new 4.5 drill.No patient injury was reported.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question will not be returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of failure without having the failed product or the pertinent clinical details to consider.As such the complaint is being closed without conclusion.However, if the product is returned in the future the complaint can be reopened and evaluated.No further investigation is required.

• Brand Name: DRILL ENDOBUTTON 4.5MM (ONST)
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8087445
• Report Number: 1219602-2018-01591
• Device Sequence Number: 13792771
• Product Code: HWE
• UDI-Device Identifier: 03596010375322
• UDI-Public: 03596010375322
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2019

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 Catalogue Number: 013184
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 11/20/2018; 02/13/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 11/20/2018; 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1