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

Model Number 2570-04-501

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

Patient Problem Bone Fracture(s) (1870)

Event Date 12/23/2019

Event Type  Injury  

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 Description

It was reported that the surgeon trialed an 11 stem, determined it was too long, then put in a 10 broach, countersunk it, then calcar planed 6-8mm of bone.During the process she noticed a fx on the calcar.She said ¿your calcar planer broke the femur¿.One cerclage cable was placed.After closing, surgeon said it wasn¿t the calcar planer, she was trying to remove too much bone all at once with it.Ten minutes surgical delay.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial 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: 9578026
• MDR Text Key: 176307548
• Report Number: 1818910-2020-01524
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2570-04-501
• Device Catalogue Number: 257004501
• Device Lot Number: PG285653
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR