MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AFFIXUS PR HUM TAR GD CNCT BLT TRAUMA INSTRUMENT

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  

Manufacturer Narrative

Medical product: humerus impaction head; catalog#: 110035647; lot#: unknown. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation. As no lot number was provided, the device history records could not be reviewed. 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).

Event Description

It was reported that the attachment for the insertion handle (the thread) jammed.

• Brand Name: AFFIXUS PR HUM TAR GD CNCT BLT
• Type of Device: TRAUMA INSTRUMENT
• 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: 12743987
• MDR Text Key: 281742985
• Report Number: 0009613350-2021-00554
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024506633
• UDI-Public: 00889024506633
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

0 Patients were 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

• Device Model Number: N/A
• Device Catalogue Number: 110035672
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2022
• 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: Unkown
• Removal/Correction Number: N/A