MAUDE Adverse Event Report: DEPUY IRELAND 9616671 MODULAR CALCAR PLANER SML; REAMERS

Catalog Number 257004501

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

During planing of the calcar in total hip replacement, there was a fracture of the calcar.This was not considered as a product complaint at the time but after further use of the instrument surgeon believes it was the instrument itself that caused this.Surgeon was not using the planer at speed, and was aware of how aggressive it was.20 minute delay to the procedure.No ae to patient.

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 investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for 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: MODULAR CALCAR PLANER SML
• Type of Device: REAMERS
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8203389
• MDR Text Key: 131630471
• Report Number: 1818910-2018-79406
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10603295482024
• UDI-Public: 10603295482024
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 257004501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention