MAUDE Adverse Event Report: ZIMMER SURGICAL S.A. UNIVERSAL OSCILLATING SAW ATTACHMENT

Catalog Number 89-8509-450-60

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer at the time of this report.A follow-up report will be submitted once the device is returned and the investigation is complete.

Event Description

It is reported that it was impossible to use the saw attachment because it was uncompleted and that pins were missing from the blade locking system.No patient involve with this event since the event occured prior to surgery.

Manufacturer Narrative

Universal oscillating saw attachment, part number 89-8509-450-60 serial number (b)(4) was returned for complaint investigation.Upon receipt, it was confirmed that some pins of the locking system were broken.The product was not repairable, it was not repaired.Since the product was not under warranty, it was not replaced.This information was reported in error under mfr #0008031000-2015-00118-1 on 23-dec-2015 (date that the initial mdr submitted in error was sent) with three additional 0¿s.This information is now being reported under manufacturing report #8031000-2015-00118-1.

Event Description

It is reported that it was impossible to use the saw attachment because it was uncompleted and that pins were missing from the blade locking system.No patient involved with this event since the event occurred prior to surgery.

• Brand Name: UNIVERSAL OSCILLATING SAW ATTACHMENT
• Type of Device: UNIVERSAL OSCILLATING SAW ATTACHMENT
• Manufacturer (Section D): ZIMMER SURGICAL S.A.; chemin pre fleuri 3; plan les ouates, geneva CH-12 28; SZ CH-1228
• MDR Report Key: 5115926
• MDR Text Key: 27574349
• Report Number: 8031000-2015-00118
• Device Sequence Number: 1
• Product Code: HAB
• 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: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2015
• 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
• 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