MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE CANNULATED REAMER 2 36 MM DIAMETER; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 when the or staff was opening for a reverse shoulder replacement the surgical technician noticed that the 36mm baseplate reamer was broken.

Manufacturer Narrative

Visual examination of the returned product identified one of the tabs has fractured off and was not returned.The device exhibits signs of wear.Prong fracture on the baseplate cannulated reamer sample performed using keyence optical microscope showed that the prong suspected to have fractured due to bending overload.Prong fracture surface showed nearly flat fracture with no major artifacts, which is indicative of fast brittle overload fracture.One of the suspected crack initiation site identified in the center of the prong fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.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.

Event Description

No additional information reported.

• Brand Name: BASE PLATE CANNULATED REAMER 2 36 MM DIAMETER
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10263534
• MDR Text Key: 198525879
• Report Number: 0001822565-2020-02509
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: K121543
• 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: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• 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: 00430904202
• Device Lot Number: 62405679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1