MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MIS QUAD-SPARING SCREW INSERTER/ EXTRACTOR; KNEE, INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 09/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product location is unknown.

Event Description

It was reported that during surgery a screw fractured and surgeon had to take it away with the clamp.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 06702, 0001822565-2018-0396.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned devices identified that the mis headed screw had fractured and the head was still lodged in the screw inserter/extractor.Device history record was reviewed and no discrepancies were found.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Root cause was unable to 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.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.

• Brand Name: MIS QUAD-SPARING SCREW INSERTER/ EXTRACTOR
• Type of Device: KNEE, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6912271
• MDR Text Key: 88132089
• Report Number: 0001822565-2017-06702
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2018

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: 00598304900
• Device Lot Number: 63458926
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 07/23/2018; 08/14/2018
• Supplement Dates FDA Received: 08/13/2018; 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1