MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMER BLADE; KNEE INSTRUMENT

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reporter had indicated that product will be returned.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 instrument was difficult to fit with the mating device during the surgery.Another device was used to complete the procedure.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Device history record was reviewed and no discrepancies relevant to the reported event were found.Visual evaluation of the returned device shows no sign of physical damage, but failed when checking with gage which is used to check the overall outer diameter.Upon closer examination it appears that the tabs were slightly deformed which would cause the mating issue and the failure of the gage.A definitive root cause cannot be determined as it could not be determined when the deformation of the tabs occurred 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

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

• Brand Name: PATELLA REAMER BLADE
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7278857
• MDR Text Key: 100519247
• Report Number: 0001822565-2018-00964
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• 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: 02/13/2019

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: 00597909541
• Device Lot Number: 63703151
• Other Device ID Number: (01) 00889024217522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/16/2018
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 63 YR