MAUDE Adverse Event Report: ZIMMER BIOMET, INC. IMPACT DRIVER GREATER TROCHANTERIC REATTACHMENT DEVICE; INSTRUMENT, EXTREMITY

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the end of the impactor fractured when it impacted with the floor after the surgeon dropped the impactor.No impact to the patient was reported.Attempts have been made and no additional information is available at this time.

Event Description

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

Manufacturer Narrative

Visual examination of the returned product identified a portion of the acetal copolymer subcomponent is fractured and missing.The threaded portion remains in the driver.Field age of the device is 21 years.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.It is alleged that the device was dropped; however a definitive root cause cannot be determined.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.

• Brand Name: IMPACT DRIVER GREATER TROCHANTERIC REATTACHMENT DEVICE
• Type of Device: INSTRUMENT, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10744734
• MDR Text Key: 213449893
• Report Number: 0001822565-2020-03640
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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: 00223201100
• Device Lot Number: 65484900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1