MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PIN; INSTRUMENT, KNEE

Model Number N/A

Device Problem Mechanical Jam (2983)

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

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05603 and 0001822565-2019-05330.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 during a knee procedure, a drill pin was cross-threaded in a cut guide and became stuck.It could not be removed from the cutting block.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The pin is fractured and exhibits signs of repeated use.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to 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.

Event Description

This follow-up report is being filed to relay that the previous report submitted was submitted erroneously under the wrong manufacturing report number.

Manufacturer Narrative

This follow-up report is being filed to relay that the previous report submitted was submitted erroneously under the wrong manufacturing report number.

• Brand Name: UNKNOWN PIN
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9481273
• MDR Text Key: 189989425
• Report Number: 0001822565-2019-05330
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 05/27/2020; 05/24/2021
• Supplement Dates FDA Received: 05/28/2020; 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1