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

Model Number N/A

Device Problems Difficult to Remove (1528); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Concomitant medical products- pin 2.5 mm diameter catalog#: 47430902501 lot#: 63906428.Drill guide and pin were returned for evaluation.Dimension taken is within specifications.The returned pin 2.5 mm diameter is bent and seized in the base plate drill guide 1 hole.Dhr was reviewed and no discrepancies were found.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.It is reported that the surgeon bent the pin in order to correct the angle in to the joint causing the pin to get jammed in the guide.It is noted in the surgical technique, "do not use excessive force when driving the 2.5mm pin into bone as this may cause it to bend or fracture." a summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-02732.

Event Description

It was reported that during a reverse total shoulder arthroplasty, the guide pin became lodged in the baseplate drill guide, after being bent by the surgeon as he attempted to correct the angle in to the joint.A new instrument was available to complete the procedure successfully.No patient consequences were reported as a result of the malfunction.

• Brand Name: TM REVERSE BASE PLATE DRILL GUIDE
• Type of Device: SHOULDER, PROSTHESIS
• 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: 7532851
• MDR Text Key: 108867579
• Report Number: 0001822565-2018-02731
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 62495446
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2013
• 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