MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVS 2.7MM DIA DRL; INSTRUMENT SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 08/26/2020

Event Type  Injury  

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.

Event Description

It was reported that the dr.Drilled the inferior locking whole of a comprehensive glenoid base plate with a 2.7 mm drill bit and the drill bit broke at the transition from the cutting edge of the bit and the shaft of the bit.Attempts have been made and there is no additional information available at this time.

Event Description

It was reported from the surgeon and sales representative that a portion of the drill bit was lodged in the scapula behind the baseplate.No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were corrected: b1, b2, h1 the following sections were updated: b4, b5, g4, g7, h2, h3, h6, h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: both images demonstrate a fractured tip of a drill bit located medial to the inferior most screw of the glenoid base plate.On the provided images, this drill bit projects upon the posterolateral superior right ribs, but is most likely not within the lungs and likely located within the superimposed soft tissues.More diagnostic evaluation of the bones and soft tissues is not optimally performed on this fluoroscopic study.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: COMP RVS 2.7MM DIA DRL
• Type of Device: INSTRUMENT SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10489960
• MDR Text Key: 205715805
• Report Number: 0001825034-2020-03422
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 405889
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other