MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNIVERSAL INSERTER/EXTRACTOR

Model Number N/A

Device Problem Misassembly by Users (3133)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(6).

Event Description

It was reported that a new inserter was received at a hospital.During initial testing of the instrument, it was said to not work properly when threading into trial ball impactors.This event did not occur surgery or have any patient involvement.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.One device was received and evaluated.Visual inspection of inserter revealed irregularities on the threads and impact marks to the end of the handle.There was significant damage to the threads.The damage makes the use of a thread ring gauge impossible.Review of the device history record identified no deviations or anomalies would contribute to reported event.A definitive root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNIVERSAL INSERTER/EXTRACTOR
• Type of Device: EXTRACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7819764
• MDR Text Key: 118330765
• Report Number: 0001825034-2018-08481
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 31-473601
• Device Lot Number: ZB180101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 01/14/2019
• Supplement Dates FDA Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1