MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X40MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

Medical products: proximal humerus, right, 9x160mm; catalog#: 47-2496-160-09; lot#: 3049707. Blunt tip screw, 4x38mm; catalog #: 47-2486-038-40; lot#: 3024673. Blunt tip screw, 4x40mm; catalog #: 47-2486-040-40; lot#: 3024691. Blunt tip screw, 4x56mm; catalog #: 47-2486-056-40; lot#: 3036148. Cortical bone screw, 4x26mm; catalog #: 47-2486-126-40; lot#: 3039758. Cortical bone screw, 4x28mm; catalog #: 47-2486-128-40; lot#: 3054491. Proximal humerus nail cap, 0mm; catalog #: 47-2488-010-00; lot#: 3054440. Therapy date: unknown. The manufacturer did not receive x-rays or other source documents for review. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, 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

It was reported that the patient was implanted with ann nail on an unknown side. Three months from the initial surgery the surgeon found that the first proximal screw had backed out from its position. The surgeon is monitoring the patient and a revision surgery has not yet been planned.

• Brand Name: BLUNT TIP SCREW, 4X40MM
• 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: 12539667
• MDR Text Key: 274445988
• Report Number: 0009613350-2021-00499
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 47-2486-040-40
• Device Lot Number: 3024681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2020
• 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: 09/28/2021 Patient Sequence Number: 1