MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM COMP RVS GLEN TRAY IMPTR; IMPACTOR

Model Number N/A

Device Problem Fracture (1260)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign event (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the instrument fractured during use.No patient harm reported per surgeon.No further information is available at the time of this reporting.

Manufacturer Narrative

No device was returned.Visual examination of the provided pictures identified the strike plate fractured from the impactor body.Complaint is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.However, it is known this device was manufactured prior to design improvements.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 information is available at the time of this reporting.

• Brand Name: 25MM COMP RVS GLEN TRAY IMPTR
• Type of Device: IMPACTOR
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8959968
• MDR Text Key: 158625542
• Report Number: 0001825034-2019-03926
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K120121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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: 405809
• Device Lot Number: 3058598
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/04/2019
• Supplement Dates Manufacturer Received: 09/11/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1