MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CORTICAL BONE SCREW, 4X26MM; AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem Joint Dislocation (2374)

Event Date 02/07/2022

Event Type  Injury  

Event Description

It was reported that operation was performed with ann nail system.After 4 months from the initial, surgeon found a 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.Patient involvement.No further outcome.

Manufacturer Narrative

Concomitant medical products: blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3010653.Blunt tip screw, 4x46mm; catalog#: 47-2486-046-40; lot#: 3024714.Blunt tip screw, 4x60mm; catalog#: 47-2486-060-40; lot#: 3054546.Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3033538.The manufacturer received x-rays and will be reviewed as part of ongoing investigation.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).The following reports are associated with this event: 0009613350-2022-00126; 0009613350-2022-00128; 0009613350-2022-00129.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information investigation results are now available.During the investigation it was concluded that the device previously submitted on this medwatch is not a contributing element for the reported event and therefore has been moved to concomitant device.Please remove 0009613350-2022- 00127 from your records.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022-00126-1; 3068920 0009613350-2022-00129-1; 0009613350-2022- 00216; 0009613350-2022-00217.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

Investigation results are now available.During the investigation it was concluded that the device previously submitted on this medwatch is not a contributing element for the reported event and therefore has been moved to concomitant device.Please remove 0009613350-2022- 00127 from your records.

• Brand Name: CORTICAL BONE SCREW, 4X26MM
• 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: 13666847
• MDR Text Key: 286570585
• Report Number: 0009613350-2022-00127
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00889024505339
• UDI-Public: 00889024505339
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47-2486-126-40
• Device Lot Number: 3068970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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 Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization
• Patient Sex: Female