MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TM REVERSE PIN 2.5 MM DIAMETER; PROSTHESIS, SHOULDER

Catalog Number 47430902501

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001822565 - 2018 - 07086 (b)(4).Concomitant medical products: 00430904300 base plate drill guide 1 lot unk.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a shoulder arthroplasty procedure, the guide pin got stuck in the guide during use and was unable to be removed.T he surgery was completed with another device without significant delay.There were no patient consequences as a result of the malfunction.No further information available.

Manufacturer Narrative

(b)(4).Examination of the returned pin along with the guide confirms the reported inability to separate the instrumentation.The devices are seized together with indications of wear and galling.It is confirmed the device(s) meet their dimensional specifications.Review of device history records was not possible as the necessary product/lot code combination(s) was not provided.Root cause was unable to be determined.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

No further information provided at the time of this reporting.

• Brand Name: TM REVERSE PIN 2.5 MM DIAMETER
• 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: 8240181
• MDR Text Key: 132921087
• Report Number: 0001822565-2019-00163
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 47430902501
• Device Lot Number: 63662169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/30/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1