MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MES SIZING/ROT GDE; SIZING/MEASURING INSTRUMENTS

Catalog Number 254400509

Device Problem Bent (1059)

Patient Problem Not Applicable (3189)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

While sizing the femur for a total knee, the surgeon was adjusting the a/p sizer to the proper position when he noticed that he had put too much pressure on it and in fact he had bent the device.It no longer freely slides up and down.I have no way of knowing at this point if it can properly read the size of the femur anymore.

Manufacturer Narrative

In the initial medwatch submitted, report source was checked in error.The complaint is not foreign.

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary: 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.

• Brand Name: ATTUNE MES SIZING/ROT GDE
• Type of Device: 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 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7498600
• MDR Text Key: 107730361
• Report Number: 1818910-2018-59205
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 254400509
• Device Lot Number: ABC19013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2014
• 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