MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BASE PLATE DRILL GUIDE 1; PROSTHESIS, SHOULDER

Model Number N/A

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint is confirmed based on the returned device.Visual inspection of the returned devices show the pin fractured and jammed in the guide.The guide was bent and the wobble was confirmed.The device history records for the were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.A definite root cause cannot be determined with the information provided.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.

Event Description

It was reported that during the shoulder arthroplasty, the targeting attachment was not assembling firmly with the instrument.There was reported difficulty with placing the guide wire, however, the device was still used in the surgery without any impact to the patient or surgery.A delay of ten minutes was noted.Return of the device noted a pin had jammed and fractured in the guide.No additional information is made available.

• Brand Name: BASE PLATE DRILL GUIDE 1
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8296496
• MDR Text Key: 134712970
• Report Number: 0001822565-2019-00300
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• 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: 00430904300
• Device Lot Number: 63199959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN PIN