MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, LEFT, 9X160MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 01/20/2022

Event Type  Injury  

Event Description

It was reported that operation was performed with ann nail. After 6 weeks from the initial, surgeon found #1 screw of the proximal screws was backed out from the proper position. The surgeon keep an eye on the patient condition as well as no revision will be planned so far.

Manufacturer Narrative

Concomitant medical products: blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3038387. Blunt tip screw, 4x46mm; catalog#: 47-2486-046-40; lot#: 3054387. Blunt tip screw, 4x46mm; catalog#: 47-2486-046-40; lot#: 3054539. Cortical bone screw, 4x26mm; catalog#: 47-2486-126-40; lot#: 3054259. Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00 ; lot#: 3068908. The manufacturer did not receive x-rays, or other source documents for review. 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). The following reports are associated with this event: 0009613350-2022-00080; 0009613350-2022-00082; 0009613350-2022-00081.

• Brand Name: PROXIMAL HUMERUS, LEFT, 9X160MM
• Type of Device: AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL
• 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: 13542801
• MDR Text Key: 285989191
• Report Number: 0009613350-2022-00079
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200814
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 47-2496-161-09
• Device Lot Number: 3033564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2020
• 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 Treatment Data

Date Received: 02/16/2022 Patient Sequence Number: 1