MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN REAMER GUIDE; INSTRUMENT

Model Number N/A

Device Problems Positioning Failure (1158); Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-06916.Concomitant medical products: item #: 00597909541, lot #: 64093400.Foreign report source: (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were not provided.The damaged/bent tabs in the reamer blade show the damages might be caused during the mating process and causes the mating issue.But, sufficient information was not provided to support this claim as the reamer guide used in procedure was not returned.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.

Event Description

It was reported that a new 41 mm patella reamer blade didn't fit with the reamer guide during a total knee arthroplasty.Subsequently, a 46 mm reamer blade was alternatively used to complete the procedure.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: UNKNOWN REAMER GUIDE
• Type of Device: 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: 9207448
• MDR Text Key: 190005842
• Report Number: 0001822565-2019-04507
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• 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
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• 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: UNKNOWN REAMER GUIDE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1