MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL OSCILLATING SAW ATTACHMENT

Catalog Number 89-8509-450-60

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2015

Event Type  malfunction  

Manufacturer Narrative

At the date of the present report, the product was not returned to the manufacturer.The investigation is then not completed.A medwatch follow-up will be submitted when the investigation is completed.

Event Description

It has been reported that three pins of the oscillating saw attachment were broken.No patient was involved in this event since it occurred prior to surgery.

Manufacturer Narrative

Oscillating saw attachment, part number 89-8509-450-60 serial number (b)(4) was returned for complaint investigation.Upon receipt, it was confirmed that 3 pins were broken.The product was not repairable, it was not returned to the customer.This information was reported in error under mfr #0008031000-2015-00103-1 on 04-dec-2015 (date that the follow-up mdr submitted in error was sent) with three additional 0¿s.This information is now being reported under manufacturing report # 8031000-2020-00103-1.

Event Description

It was reported that three pins of the oscillating saw attachment were broken.No patient was involved in this event since it occurred prior to surgery.

• Brand Name: UNIVERSAL OSCILLATING SAW ATTACHMENT
• Type of Device: UNIVERSAL OSCILLATING SAW ATTACHMENT
• Manufacturer (Section D): ZIMMER SURGICAL SA; chemin pre fleuri 3; plan-les-ouates, geneva CH-12 28; SZ CH-1228
• MDR Report Key: 5017234
• MDR Text Key: 24659389
• Report Number: 8031000-2015-00103
• Device Sequence Number: 1
• Product Code: DWI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Followup
• Report Date: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8509-450-60
• Device Lot Number: 5000951
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1