MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRECISION FLEXIBLE REAMER DISPOSABLE 8.0MM

Model Number N/A

Device Problems Fracture (1260); Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reported event is confirmed.Products were returned; therefore, the visual inspection identified two breaks in the flexible reamer.Material composition and dimensional evaluation confirmed the device was within specification.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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 during an acl repair, the reamer was difficult to move forward over the guide pin.Subsequently, the reamer was removed and found to be broken.No adverse events have been reported as a result of the malfunction.Attempts have been made and no further information has been provided.

• Brand Name: PRECISION FLEXIBLE REAMER DISPOSABLE 8.0MM
• Type of Device: REAMER
• 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: 7351197
• MDR Text Key: 103170409
• Report Number: 0001825034-2018-02037
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• 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: 110004186
• Device Lot Number: 585220
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2015
• 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