MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW DRILL 3.2 MM DIAMETER; INSTRUMENT

Model Number N/A

Device Problems Separation Failure (2547); Mechanical Jam (2983); Difficult or Delayed Separation (4044)

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

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: foreign (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00889.

Event Description

It was reported that during an initial knee procedure that the drill bit that the surgeon was utilizing was jammed in the cut guide and the surgeon had to proceed with the surgery using a different guide and drill bit.No additional patient consequences were reported.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Event Description

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

Event Description

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

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g4, g7, h1, h2, h3, h6, h10 d4: udi # (b)(4).Visual examination of the returned product identified the drill was seized in one of the guide holes on the cut guide.Both instruments exhibited signs of repeated use.The drill had a bent shaft and damaged flutes.The complaint is confirmed by the product evaluation.Review of the device history records identified no deviations or anomalies.Medical records were not provided.These lots were manufactured in march 2000 and august 2016 and have been used in an unknown number of surgeries.Per the instrument/provisional use and care package insert, instruments should be carefully inspected before each use and should not be used if the instruments are marred or worn.The root cause is attributed to wear and tear from use as the cut guide used with the drill has an approximate field age of 19 years 10 months and exhibits signs of repeated use.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: BONE SCREW DRILL 3.2 MM DIAMETER
• Type of Device: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9828592
• MDR Text Key: 196385314
• Report Number: 0001822565-2020-00890
• Device Sequence Number: 1
• Product Code: HTW
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• 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: 00512008500
• Device Lot Number: 63434975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: ITEM 000599707600, LOT 664525700.