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

Model Number N/A

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

Cmp-(b)(4).Report source, foreign ¿ events occurred in (b)(6).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.

Event Description

It was reported that when impacting the stem pieces of metal flaked off the impactor end into the patient.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This report is being submitted to relay additional information.The device was returned to the manufacturer for evaluation.Visual inspection of the returned device shows proximal weld between the shaft & handle fractured confirming the complaint.The device also shows typical superficial wear marks consistent with a used surgical instrument.Further analysis of the fracture by scanning electron microscopy (sem) showed the shaft had fractured from the handle in the longitudinal direction, fracturing the weld all around the proximal surface perimeter with some missing fractured pieces that were not returned.Material analysis on the returned device confirms the weld and proximal handle were manufactured to specification.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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

It was reported that when impacting a femoral stem, pieces of metal flaked off the impactor end.The impactor broke, and a piece of it fell off into the patient.The piece was removed from the wound, and another device was found to insert the stem.Attempts have been made, and no further information has been provided.

• 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: 7097148
• MDR Text Key: 94153382
• Report Number: 0001825034-2017-10902
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 31-473601
• Device Lot Number: ZB170301
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 06/19/2018
• Supplement Dates FDA Received: 06/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention