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

Model Number N/A

Device Problem Mechanical Jam (2983)

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

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant devices - persona 4-in-1 anterior referencing cut guide size 4 catalog #: 42509908556 lot #: 64327056.Report source - foreign: (b)(6).The disposable single-use drill pin was reportedly used multiple times to reduce costs.The complainant has not yet indicated whether 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 patient; please see all reports associated with this event: 0001822565-2021-00103, 0001822565-2021-00104.Investigation incomplete.

Event Description

It is reported that the drill pin became jammed within the cutting guide during knee arthroplasty.The disposable pin had reportedly been used multiple times prior to this incident.No adverse events were reported as a result of this malfunction.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned guide showed signs of repeated use and the headless trocar drill pin was seized in one of the guide holes while the other guide hole was found to have scratches and burrs.The pin was identified to have signs of repeated use and the hex feature had fractured off.Dimensional analysis of the products determined that it was conforming to print specifications where measured.The device history records could not be reviewed as the lot number associated with the reported event is unknown.Per the instructions for use, reuse of a single use device that has come into contact with blood, bone, tissue or other bodily fluids may lead to patient or user injury.Risks associated with reuse of a single use device include, but are not limited to, mechanical failure and transmission of infectious agents.However, a definitive root cause could not be determined with the information provided.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: NEXGEN HEADLESS TROCAR DRILL PIN 3.2MM DIAMETER 75MM LENGTH
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11150900
• MDR Text Key: 226266024
• Report Number: 0001822565-2021-00103
• Device Sequence Number: 1
• Product Code: LXH
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1