MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.7X160MM CALIBRATED DRILL STE; BIT, DRILL

Model Number N/A

Device Problem Separation Failure (2547)

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

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) concomitant medical products: 110008317, alps mis drill guide lk 2.7 mm, 047790.(b)(6).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 reports: 0001825034-2018-00281.

Event Description

It was reported that during the procedure the drill was stuck with the guide, and the drill could not move in any direction.The surgeon used another drill and guide to complete the procedure.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The drill bit is stuck in the drill guide.This complaint is therefore confirmed.The outer diameter of the drill was measured and found to be in conformance with specifications.It was not possible to measure the inner diameter of the guide, due to the presence of the drill.Dhr was reviewed and no discrepancies relevant to the reported event 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.

Manufacturer Narrative

(b)(4).This follow-up report is being filled to relay a additional information, which was unknown at the time of the initial medwatch.Concomitant medical products: product id: 856135034, 3.5x34mm cort lock scr ste, lot 929710; product id: 856135038, 3.5x38mm cort lock scr ste, lot 060760; product id: 856135038, 3.5x38mm cort lock scr ste, lot 109440; product id: 856135040, 3.5x40mm cort lock scr ste, lot 579480; product id: 110016972, mis calc plt sm lt ste, lot 945040.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.

• Brand Name: 2.7X160MM CALIBRATED DRILL STE
• Type of Device: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7206972
• MDR Text Key: 98093958
• Report Number: 0001825034-2018-00280
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 214227160
• Device Lot Number: 937480
• Other Device ID Number: (01)00887878024979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2017
• Initial Date FDA Received: 01/19/2018
• Supplement Dates Manufacturer Received: 01/15/2018; 04/26/2018
• Supplement Dates FDA Received: 02/11/2018; 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1