MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALPS MIS DRILL GUIDE LK 2.7MM; PLATE, FIXATION

Model Number N/A

Device Problem Separation Failure (2547)

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

Event Date 12/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) concomitant medical products: 214227160, 2.7 x 160 mm calibrated drill ste, unknown.(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: 0001825034-2018-00279.

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

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.One of the two drill guides failed dimensional analysis of the inner diameter, although it is inconclusive whether the observed blockage was due to damage from use or from manufacturing.The other guide could not be dimensionally analyzed as the drill remained stuck in the guide.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.The following sections were updated: name and address.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: ALPS MIS DRILL GUIDE LK 2.7MM
• Type of Device: PLATE, FIXATION
• 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: 7206898
• MDR Text Key: 98068430
• Report Number: 0001825034-2018-00278
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK132898
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• 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: 110008317
• Device Lot Number: 210790
• Other Device ID Number: (01)00887869076671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1