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

Model Number N/A

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi: n/a.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.Multiple mdr reports were filed for this event, please see associated report: 0001825034-2020-03220.

Event Description

It was reported that a 2.7 drill bit was involved along with a 2.0/2.7 double drill guide.The surgeon was holding the drill guide in his hand with 2.7 drill bit through the 2.7 hole and attached to drill.When the drill was fired to turn the drill bit in the guide testing before use in the patient the drill bit was lodged and stuck in guide.Drill bit seized immediately and broke.Attempts have been made and there is no additional information available.

Event Description

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

Manufacturer Narrative

The event is confirmed with product received.Visual examination of the returned product/provided pictures identified the drill bit has broken off on both ends of the guide.Not all the fractured pieces of the drill bit were returned.Device history record review was unable to be performed as the part and lot number of the device involved in the event is unknown.The root cause of the reported issue is attributed to design deficiency.A corrective action was initiated as a result of the investigation of this event.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: UNKNOWN DRILL BIT
• Type of Device: INSTRUMENT TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10460789
• MDR Text Key: 205952397
• Report Number: 0001825034-2020-03345
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

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: 08/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: CAT#: 233500004 DRILL GUIDE LOT#: 516349.; UNK DRILL GUIDE.
• Patient Age: 21 YR
• Patient Weight: 113