MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PIN 2.5 MM DIAMETER; PROSTHESIS, SHOULDER

Catalog Number 47430902501

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source; foreign, the event occurred in the (b)(6).The event was reported to zimmer biomet through (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up/final report will be submitted.Device evaluated by manufacturer? discarded at site.

Event Description

It was reported the drill pin fractured during use and was unable to be retrieved from the patient glenoid.The surgery was completed without further issue.No further information is available at this time.

Manufacturer Narrative

It was determined this reporting is a duplication of 0001822565-2019-04655.Please void this submission and refer to 0001822565-2019-04655 for any further event communication.

Event Description

It was determined this reporting is a duplication of 0001822565-2019-04655.Please void this submission and refer to 0001822565-2019-04655 for any further event communication.

• Brand Name: PIN 2.5 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9447019
• MDR Text Key: 170142720
• Report Number: 0001822565-2019-05202
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024274273
• UDI-Public: 00889024274273
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 47430902501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other