MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLA REAMING SYSTEM PATELLA REAMER BLADE WITH PILOT HOLE; INSTRUMENATATION

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).Foreign - (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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.

Event Description

It was reported that a new 41mm patella reamer blade didn't fit with reamer guide during a total knee arthroplasty.Subsequently, a 46mm reamer blade was alternatively used to complete the procedure.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Udi # (b)(4).Reamer guide item # unknown lot # unknown.Initial reporter name/address: (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-04507.Complaint sample was evaluated and the reported event was not confirmed.Visual evaluation of the returned patella reamer shows nicks and gouges indicating the sign of use.The measured dimension of the pilot holes was conforming to print.The 2 tabs were bent and causes to fail the reamer blade overall diameter max positioning test.However, while performing the slot functional test, the instrument passed.A review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.The damaged/bent tabs in the reamer bladed 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 mating instrument 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

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

• Brand Name: PATELLA REAMING SYSTEM PATELLA REAMER BLADE WITH PILOT HOLE
• Type of Device: INSTRUMENATATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8174899
• MDR Text Key: 130790623
• Report Number: 0001822565-2018-06915
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• 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: 00597909541
• Device Lot Number: 64093400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1