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

Catalog Number 00597909546

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: patella reamer shaft, catalog # 00512007746, lot # 52031800.Report source: foreign source - (b)(6).Product has been received by zimmer biomet and 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 would not assemble with the mating instrument during a total knee arthroplasty.Another instrument was used to complete the procedure.Attempts have been made and additional information on the reported event is unavailable.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Udi: (b)(4).This follow-up report is being submitted to relay additional information.Visual evaluation of the devices exhibits signs of repeated use (nicked, gouged, surface scratches).Reamer blade's pilot hole was checked with pin gauges and the overall dimension of both instruments found to be within specification.The functional test found the reamer blade passes the slot test and failed the outer max diameter test due to damaged tabs.These instruments are mateable instruments.However, in this case, the instrument having a problem related to mating; which might be due to damaged tabs.A review of the device history record including supplier dhr of reamer blade identified no deviations or anomalies during manufacturing related to the reported event and review of the device history record for reamer guide identified no deviations or anomalies during manufacturing.The supplier dhr for the reamer guide will be reviewed as this instrument is been in used for more than 10 years.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report 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: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8412748
• MDR Text Key: 138547135
• Report Number: 0001822565-2019-01072
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00597909546
• Device Lot Number: 63931521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1