MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE FEMUR DRILL SIZE 1-2; ATTUNE INSTRUMENTS : PATELLA/FEMORAL DRILLS

Catalog Number	254500041
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # = > (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary = > the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Based on the inability to determine a root cause, a need for corrective action is not indicated.
Event or Problem Description
It was reported that the long intramedullary distal femoral cutting guide exited the canal.
Additional Manufacturer Narrative
Product complaint # = > pc(b)(4) investigation summary = > the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided as the reported device was not returned for evaluation.Based on the inability to determine a root cause, a need for corrective action is not indicated.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE FEMUR DRILL SIZE 1-2
• Common Device Name: ATTUNE INSTRUMENTS : PATELLA/FEMORAL DRILLS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46582
• MDR Report Key: 7154048
• Report Number: 1818910-2017-52714
• Device Sequence Number: 19279231
• Product Code: HWE
• UDI-Device Identifier: 10603295130482
• UDI-Public: 10603295130482
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 254500041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 12/29/2017; 12/28/2017
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 12/29/2017; 01/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 78