MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PAT RMR BLD W/PILOT HLE; KNEE INSTRUMENT

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: patella reamer blade; p/n: 00597909541, l/n: 64018812, pat rmr bld; p/n: 00597909546, l/n: 64270358.Report source: (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 02769, 0001822565 - 2019 - 02770.

Event Description

It was reported during surgery that an instrument will not mate with compatible instrument as expected during use.Subsequently, the surgery was completed with a different instrument.Attempts have been made and no further information has been provided.

Event Description

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

Manufacturer Narrative

Complaint sample was evaluated and the reported event was not confirmed.Visual examination of the returned product identified no sign of use.Instrument passes both functional tests and dimensional analysis.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.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.

• Brand Name: PAT RMR BLD W/PILOT HLE
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8750413
• MDR Text Key: 149807199
• Report Number: 0001822565-2019-02770
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

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: 00597909546
• Device Lot Number: 64270358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1