MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

Investigation of this incident is currently ongoing. A followup/ final report will be submitted when additional information becomes available. Zimmer reference (b)(4). Concomitant medical products: blunt tip screw, 4x50mm catalog: 47-2486-050-40 lot: 3024741, blunt tip screw, 4x65mm catalog: 47-2486-065-40 lot: 3039406, cortical bone screw, 4x24mm catalog: 47-2486-124-40 lot: 3078234, cortical bone screw, 4x26mm catalog: 47-2486-126-40 lot: 3078193, proximal humerus nail cap, 10. 5x5mm catalog: 47-2488-010-05 lot: 3068499. Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00257, 0009613350-2022-00260 and 0009613350-2022-00261.

Event Description

It was reported that 5 weeks after initial surgery, one of the proximal screws had backed out from the proper position. The surgeon is keeping an eye on the patient condition. No revision surgery will be planned so far. Attempts have been made and no further information has been provided.

• Brand Name: PROXIMAL HUMERUS, RIGHT, LONG, 8.5X240MM
• Type of Device: AFFIXUS NATURAL NAIL 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: 14237396
• MDR Text Key: 290289295
• Report Number: 0009613350-2022-00256
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505964
• UDI-Public: 00889024505964
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 47-2496-240-08
• Device Lot Number: 3068960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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: 04/28/2022 Patient Sequence Number: 1