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

Catalog Number 254400519

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  malfunction  

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 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
• Type of Device: ATTUNE INSTRUMENTS : SIZING/MEASURING INSTRUMENTS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 8894432
• MDR Text Key: 155691897
• Report Number: 1818910-2019-101116
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295384403
• UDI-Public: 10603295384403
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR