MAUDE Adverse Event Report: ZIMMER SURGICAL SA OSCILLATING SAW ATTACHMENT

Catalog Number 89-8509-450-60

Device Problems Activation, Positioning or SeparationProblem (2906); Detachment of Device or Device Component (2907); Knife (3156)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 07/10/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer at the date of this report. A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.

Event Description

It was reported that the oscillating saw attachment part number 89-8509-450-60, serial number (b)(4), failed to hold the blade during osteotomy. The surgery delay was 45 minutes due to the time needed to sterilize another device to complete the surgery. There was no additional harm or injury to patient/operator reported.

• Brand Name: OSCILLATING SAW ATTACHMENT
• Type of Device: OSCILLATING SAW ATTACHMENT
• Manufacturer (Section D): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates, geneva 1228 ; SZ 1228
• Manufacturer (Section G): ZIMMER SURGICAL SA; 3, ch. du pre fleuri; plan-les-ouates, geneva 1228 ; SZ 1228
• Manufacturer Contact: christina arnt ; 56 e. bell drive; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7804317
• MDR Text Key: 117835804
• Report Number: 0008031000-2018-00022
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (Y/N): N
• Reporter Country Code: KE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Type of Report: Initial,Followup
• Report Date: 11/30/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 08/22/2018
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 89-8509-450-60
• Device LOT Number: 5005954
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 02/05/2015
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 08/22/2018 Patient Sequence Number: 1