MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE BAL SIZER DISTRACTOR; ATTUNE INSTRUMENTS : SIZING/MEASURING INSTRUMENTS

Catalog Number	254400519
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned device found the actuation feature to be jammed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the surgeon uses a combination of the ap measured sizer and the balancing sizer in his total knee arthroplasty's.He first sizes the knee with the measured sizer to get an idea of what size he's looking at, and then uses the balanced sizer to confirm.After dr.Finished using the balanced sizer completely and took it off, he noticed that the 2 pieces that make up the attune balanced sizer distractor rod seemed to be cross-threaded and could not be loosened back up.This did not delay the case in any way as surgeon was already finishing using it and continued to proceed to the next step.Replacements are needed to complete the femoral sizing and finishing tray.Upon examination, the internal rod component of the device was found to be jammed/frozen.

• Brand Name: ATTUNE BAL SIZER DISTRACTOR
• Common Device Name: ATTUNE INSTRUMENTS : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8894432
• Report Number: 1818910-2019-101116
• Device Sequence Number: 13843366
• Product Code: HWT
• UDI-Device Identifier: 10603295384403
• UDI-Public: 10603295384403
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2019

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: 254400519
• Device Lot Number: ABB25484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR