MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN DRILL BIT; INSTRUMENT

Model Number N/A

Device Problems Fracture (1260); Separation Failure (2547)

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

Event Date 05/10/2019

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.Report source: the event occurred in (b)(6).

Event Description

It was reported that the drill bit is stuck inside cut guide hole.The piece of the drill bit was broken, and a piece is still inside the cut guide, and cannot be removed.No pieces fell into the patient.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

(b)(4).Report source foreign: canada.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified a fractured drill pin is lodged in one of the holes of the device.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were not provided.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not 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: UNKNOWN DRILL BIT
• Type of Device: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8744939
• MDR Text Key: 149638519
• Report Number: 0001822565-2019-02418
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 10/14/2019
• Supplement Dates FDA Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1