MAUDE Adverse Event Report: ZIMMER, INC. BIGLIANI/FLATOW GLENOID INSTRUMENT STRAIGHT SPOKE REAMER ASSEMBLY; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show the lot released with no recorded anomaly or deviation.

Event Description

It is reported that the screw attachment part of the reamer fractured off inside the reamer shaft.

Manufacturer Narrative

This report is being submitted to reflect additional information not previously available.The reamer was returned for investigation.Hardness and dimension taken are both within specification.The screw and reamer fractured.This instrument had a potential field age of approximately two years.This device is used for treatment.A complaint history review was conducted and identified no additional complaints for the part and lot numbers.A definite root cause cannot be determined with the information provided.

• Brand Name: BIGLIANI/FLATOW GLENOID INSTRUMENT STRAIGHT SPOKE REAMER ASSEMBLY
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6264529
• MDR Text Key: 65303549
• Report Number: 0001822565-2017-00308
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• 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: 00-4307-030-52
• Device Lot Number: 62725065
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2014
• 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
• Patient Age: 76 YR