MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE REV FEM BROACH STOP R; DRILL GUIDES

Catalog Number	254600106
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
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.Device was used for treatment, not diagnosis.Initial reporter is a sales representative device is not distributed in the united states, but is similar to device marketed in the usa.
Event or Problem Description
It was reported two broach handles were not catching and a broach stop right was vibrating off the handle during use.The issue occurred during surgery on (b)(6) 2019.The femoral broach was lodged in the femoral canal, with the surgeon unable to remove it.Both broach handles were used, but he couldn¿t get the broach dislodged.A different instrument was used to get the broach out.Surgery was extended by about fifteen (15) minutes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > the device was reviewed by bioengineering and a report was received which could not confirm the failure modes as reported.Root cause undetermined.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 REV FEM BROACH STOP R
• Common Device Name: DRILL GUIDES
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8316220
• Report Number: 1818910-2019-83585
• Device Sequence Number: 13464517
• Product Code: LXH
• UDI-Device Identifier: 10603295450924
• UDI-Public: 10603295450924
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 254600106
• Device Lot Number: AB4126036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 02/07/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1