MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV FEM BROACH M-L 40; BROACHES

Model Number	2511-01-104
Medical Device Problem Codes	Connection Problem (2900); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Not Applicable (3189)
Date of Event	11/04/2019
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.
Event or Problem Description
Could not get femoral trial to engage & lock to broach with revision femoral broach bolt.Tried both bolts - neither successful.Screwed in and torqued however did not lock enough to maintain rotation.This meant that we could not lock the rotation of the femoral trial to the broach for replication of real implant.This meant the rotation of the implant was not accurate and femur fractured on insertion of implant.Surgeon removed implant and placed a cable then re-implanted femur with eventual success.Bolts worked with broaches above and beyond the 40mm but not the 40mm one.20 minute delay to the procedure.Patient outcome post surgery: patient post op xray looked in good alignment.Surgeon was happy with outcome.2 cables placed around femur.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE REV FEM BROACH M-L 40
• Common Device Name: BROACHES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9378691
• Report Number: 1818910-2019-118190
• Device Sequence Number: 2146919
• Product Code: HTQ
• UDI-Device Identifier: 10603295437963
• UDI-Public: 10603295437963
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 11/04/2019

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 Model Number: 2511-01-104
• Device Catalogue Number: 251101104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 11/27/2019; 01/20/2020
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/04/2019; 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR