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

Catalog Number 89-8509-450-60

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2015

Event Type  malfunction  

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.

Event Description

It was reported that the pins to mount the saw blade from universal oscillating saw attachment, serial number (b)(4), were broken.No patient harm or injury or delay were reported.

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 the eccentric system was seized and some pins were broken.The product was not repairable.This information was reported in error under mfr #0008031000-2015-00115-1 on 16-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 #8031000-2015-00115-1.

Event Description

It was reported that the pins to mount the saw blade were broken.No patient harm or injury or delay were reported.

• 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: 5112988
• MDR Text Key: 27218730
• Report Number: 8031000-2015-00115
• 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: 09/30/2015
• 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: AF56723
• Was Device Available for Evaluation?: No
• 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