MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH; ORTHOPEDIC STEREOTAXIC INSTRUMENT, KNEE

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2021-01574.Concomitant medical product: degree distal cut block, item# 42509901000, lot# 63842130.The product has been returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a trocar pin got stuck in the cutting block.The block was removed from the patient and a new cutting block was used.There is no additional information available.

Event Description

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

Manufacturer Narrative

This follow-up is being submitted to relay additional information.Visual examination of the returned products identified signs of repeated use for both devices.The trocar drill pin is seized in one of the guide holes of the distal cut guide.Dimensional analysis of the trocar drill pin determined that the product, where measured, was conforming to print specifications.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.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.

• Brand Name: HEADLESS TROCAR DRILL PIN 3.2 MM DIAMETER 75 MM LENGTH
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11948073
• MDR Text Key: 254636770
• Report Number: 0001822565-2021-01575
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00889024201620
• UDI-Public: (01)00889024201620(17)301212(10)64957279
• Combination Product (y/n): N
• PMA/PMN Number: K182964
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• 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: 00590102000
• Device Lot Number: 64957279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Weight: 80