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

Model Number N/A

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

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

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant: 214227160, 2.7x160mm calibrated drill ste, 441700.(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 - 2017 - 11350.

Event Description

It was reported that during the procedure the drill was stuck with the guide.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 filled to relay a additional information, which was unknown at the time of the initial medwatch.Concomitant medical products: 110016966 mis calc plt sm extd 2h lt ste 330460; 856135026 3.5x26mm cort lock scr ste 969550; 856135028 3.5x28mm cort lock scr ste 262360; 856135030 3.5x30mm cort lock scr ste 579150; 856135030 3.5x30mm cort lock scr ste 929580; 856135034 3.5x34mm cort lock scr ste 204040; 856135034 3.5x34mm cort lock scr ste 467460; 856135034 3.5x34mm cort lock scr ste 579360; 856135042 3.5x42mm cort lock scr ste 551960.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.

Event Description

It was reported the drill became stuck in the guide during a repair of a fractured calcaneus.The surgery was completed with other devices after a 15 minute delay to surgery.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event could not be confirmed.Inspection of the returned device revealed no evidence of wear along the shaft of the drill, and abrasions approximately 3.25 inches from the tip.These abrasions stop the drill and prevent it from advancing further through the guide, while also preventing rotation.Based on this examination, this complaint is confirmed.Dimensional analysis was not conducted on the drill, due to the damage noted.Dimensional analysis was performed on outer diameter of the drill and the inner diameter of the guide.The drill was measured with a caliper at five points along the shaft, and all measurements were in conformance to product specifications.The guide was measured with a pin gage, and also found to be in conformance with specifications.It is noted, that the measurement for the drill guide was at the low end of the print tolerance.It is also noted, however, that the drill measured at the low end of its tolerance as well.Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event.Root cause of the event could not 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 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: 7151929
• MDR Text Key: 96024805
• Report Number: 0001825034-2017-11351
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PN/A
• 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: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: No
• 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