MAUDE Adverse Event Report: BIOMET TRAUMA ALPS CALIBRATED DRILL 2.7X160MM; BIT, DRILL

Catalog Number 214227160

Device Problems Difficult to Insert (1316); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog number 110008317 lot number 210790 - alps mis locking drill guide 2.7mm.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.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2017-01644 / 01645).

Event Description

It was reported that during a plating procedure, after drilling, the drill got stuck in the locking drill guide.No adverse events have been reported as a result of the malfunction.The doctor removed the drill from the guide with pliers.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The drill bit advances approximately 1 3/4" into the guide before meeting significant resistance.It can ultimately be pushed through and pulled back out, but only with force.This confirms the complaint of a jam.There is damage to the flutings of the drill bit which keeps the bit from moving smoothly through the guide.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action(s) is/are required.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.

• Brand Name: ALPS CALIBRATED DRILL 2.7X160MM
• Type of Device: BIT, DRILL
• Manufacturer (Section D): BIOMET TRAUMA; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6409088
• MDR Text Key: 70081334
• Report Number: 0001825034-2017-01645
• 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: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 214227160
• Device Lot Number: 089220
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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