MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL STANDARD 2.0 MM DIAMETER; BIT, DRILL

Catalog Number 00236017520

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source: foreign-(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the drill bit was found broken before the surgery.There was no patient involvement or harm to the patient as a result of this malfunction.

Manufacturer Narrative

(b)(4).Visual inspection of the provided pictures noted the tip of the drill fractured, confirming the complaint.Device history record (dhr) was reviewed and no discrepancies were found.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 additional event information is available at the time of this report.

• Brand Name: DRILL STANDARD 2.0 MM DIAMETER
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9902710
• MDR Text Key: 185713275
• Report Number: 0001822565-2020-00938
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00236017520
• Device Lot Number: 63914587
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1