MAUDE Adverse Event Report: ZIMMER BIOMET, INC. GLENOID INSTRUMENT 46 MM STRAIGHT SPOKE REAMER ASSEMBLY; SHOULDER, INSTRUMENTS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01554.

Event Description

It was reported the initial shoulder arthroplasty, the reamer broke off the handle.No patient was involved during the malfunction.No additional information is available.

Event Description

No additional information is available to report at this time.

Manufacturer Narrative

The following report is being submitted to relay additional information received: complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the reamer has fractured.Dimensions taken on the reamer are confirming.The reamer has field age of approximately 5 years and driver has a field age of approximately 5 years, 6 months and it is unknown how many times they were used.Review of the device history record(s) identified no deviations or anomalies.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: GLENOID INSTRUMENT 46 MM STRAIGHT SPOKE REAMER ASSEMBLY
• Type of Device: SHOULDER, INSTRUMENTS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8516084
• MDR Text Key: 141992276
• Report Number: 0001822565-2019-01553
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K103404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00430703046
• Device Lot Number: 62629914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: 00430707400 CANNULATED STRAIGHT DRIVER 62356352; 00430707400 CANNULATED STRAIGHT DRIVER 62356352