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

Model Number N/A

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

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog #unknown, unknown guide pin, lot# unknown.(b)(6).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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03020.

Event Description

It was reported that during a workshop before a shoulder arthroplasty surgery, the surgeon tried moving the pin through the drill guide but was unable to do so.The pin became stuck inside the guide.The surgery was completed using a different device.No patient impact was reported as there was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual inspection shows scratches and dings along the surface likely from prior use.This item has a piece of an unknown pin seized inside of the hole.The returned items do not contain an etch so identification cannot be determined.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.A summary of the investigation has been sent to the complainant.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.

• Brand Name: TM REVERSE 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: 7562410
• MDR Text Key: 109834439
• Report Number: 0001822565-2018-03019
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PK052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00430904300
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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