MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 11X160MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/18/2021

Event Type  Injury  

Manufacturer Narrative

Medical product: blunt tip screw, 4x48mm; item# : 47248604840; lot# : 3024731. Blunt tip screw, 4x46mm; item# : 47248604640; lot# : 3039376. Blunt tip screw, 4x46mm; item# : 47248604640; lot# : 3062600. Cortical bone screw, 4x32mm; item# : 47248613240; lot# : 3010610. Proximal humerus nail cap, 10. 5x2. 5mm; item# : 47248801002; lot# : 3025182. Proximal humerus nail cap,11x2. 5mm; item# : 47248801102; lot# : 3038374. Therapy date: (b)(6) 2021. The manufacturer received x-rays and other source documents for review. The device history records were reviewed and found to be conforming. 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

Patient was implanted on an unknown side. 1 week post the surgery, it was noticed by the surgeon that the blunt screw gradually backed out from the proper position. A revision surgery was performed and during the revision only the blunt screw was explanted.

• Brand Name: PROXIMAL HUMERUS, RIGHT, 11X160MM
• 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: 12421520
• MDR Text Key: 269786483
• Report Number: 0009613350-2021-00446
• 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,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 47-2496-160-11
• Device Lot Number: 3051302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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: 09/03/2021 Patient Sequence Number: 1