MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH EXTRACTOR FOR TRIAL HUMERAL STEM; ANATOMICAL SHOULDER SYSTEM

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2021

Event Type  malfunction  

Event Description

It was reported that pieces of the stem extractor from the anatomic shoulder became fused after use and jammed.

Manufacturer Narrative

Medical product: as fx extension rod; catalog#: 0104236115; lot#: 15215065.The manufacturer did receive photographs and will be reviewed as part of ongoing investigation.The manufacturer did receive the device and will be reviewed as part of ongoing investigation.The lot number of the device was received.The device history records will be reviewed during investigation.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: EXTRACTOR FOR TRIAL HUMERAL STEM
• Type of Device: ANATOMICAL SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12743995
• MDR Text Key: 281159627
• Report Number: 0009613350-2021-00555
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024301825
• UDI-Public: 00889024301825
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193099
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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: 72.01.00-02
• Device Lot Number: 4501802409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• 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