MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 4.4MM DRILL SLEEVE; INSTRUMENT, MANUAL

Model Number N/A

Device Problem Corroded (1131)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2014

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).Complaint sample was evaluated and the reported event was not confirmed.Based on dhrs, the product was made to print and correct materials.Product left conforming to print as there was no evidence that states otherwise.Product likely failed due to misuse, by instrument being put through excessive force or torsional/bending overload, and/or not inspected for wear and disfigurement and prior to surgery or rekitting, which may have prevented the use of the instrument and its failure.The mention of debris, rust, corrosion and contaminates in email correspondence was not identified on product returned.This was not a supplier issue.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.Investigation results concluded that the reported event was due to customer error: instrument damaged or worn beyond useful life and improper torque.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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 the sheaths and trochars are described as "damaged" at tip and at entry points.The entry reamer is also chipped.There is also reports of contaminates/rust and debris.This was discovered as the trays were opened and did not occur during a procedure.

• Brand Name: 4.4MM DRILL SLEEVE
• Type of Device: INSTRUMENT, MANUAL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7112973
• MDR Text Key: 95745988
• Report Number: 0001825034-2017-11085
• Device Sequence Number: 1
• Product Code: HBD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• 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: 281012012
• Device Lot Number: C131N4
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1