MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE DRILL 3.2 MM DIAMETER 45 MM LENGTH; INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that this instrument broke.No known patient involvement.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.As returned, both devices exhibit dull cutting edges.The tip of the drill bit of lot 72606900 is fractured and missing.Device history record (dhr) was reviewed and no discrepancies were found.Unlikely a manufacturing issue due to amount of time item has been in the field and exhibits heavy damage from use.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 further event information available at the time of this report.

• Brand Name: FLEXIBLE DRILL 3.2 MM DIAMETER 45 MM LENGTH
• Type of Device: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8485416
• MDR Text Key: 141018873
• Report Number: 0001822565-2019-01413
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• 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: 00661100303
• Device Lot Number: 72606900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1