MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ZUK FEMORAL REAMER .270; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESSORY/ATTACHMENT

Catalog Number	00584305100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the femoral drill is dull, needs excessive force to drill in.The drill was then stuck, could not get out.A delay less than 30 min was reported.A backup device was not available.No injury reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.

• Brand Name: ZUK FEMORAL REAMER .270
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR/ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8254307
• Report Number: 1020279-2019-00187
• Device Sequence Number: 1929261
• Product Code: HWE
• UDI-Device Identifier: 00885556621646
• UDI-Public: 00885556621646
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2019

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: 00584305100
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 04/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1