MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X38MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

Model Number N/A

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: cortical bone screw, ã¿ 4x28mm; catalog no#: 47-2486-128-40; lot#: 3010598. Cortical bone screw, ã¿ 4x30mm; catalog no#: 47-2486-130-40; lot#: 2999921. Proximal humerus nail cap, 0mm; catalog no#: 47-2488-010-00; lot#: 3008334. Therapy date: (b)(6) 2020. The manufacturer did receive x-rays and implant pictures 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. (b)(4).

Event Description

Patient was implanted on the unknown side and underwent revision surgery due to screws were backed out.

• Brand Name: BLUNT TIP SCREW, 4X38MM
• 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: 10598833
• MDR Text Key: 209004867
• Report Number: 0009613350-2020-00432
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 47-2486-038-40
• Device Lot Number: 3010634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 09/29/2020 Patient Sequence Number: 1