MAUDE Adverse Event Report: TORNIER INC TORNIER HRS ASSEMBLY SCREW 0MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number ARS655101

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device not returned.

Event Description

The end user reported that the 0mm assembly screw was too short and couldn't be use to attach the proximal and distal body of the revive humeral prosthesis to each other.

Manufacturer Narrative

The reported event that could not be confirmed.The device has not been returned and no other evidence has been provided for investigation.A device inspection was not possible since the affected device was not returned, and no other evidence has been provided.A review of the labeling and device history for the reported lot did not indicate any abnormalities.No indications of material or design related problems were found during the investigation.This event has been escalated to a capa within our quality system for further investigation.Based on the investigation, the root cause was attributed to a manufacturing related issue.It was discovered that ars655118 lot az1822082 (quantity (b)(4)) and ars655101 lot az1322077 (quantity (b)(4)) were processed through packaging at the same time.The supplier stated they believe this is a complete swap of lots.They have opened a capa on their end to formalize the root cause and escape.If any additional information is provided, the investigation will be reassessed.

Event Description

The end user reported that the 0mm assembly screw was too short and couldn't be use to attach the proximal and distal body of the revive humeral prosthesis to each other.

• Brand Name: TORNIER HRS ASSEMBLY SCREW 0MM
• Type of Device: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17213495
• MDR Text Key: 318001772
• Report Number: 0001649390-2023-00147
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00846832093250
• UDI-Public: 00846832093250
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K181420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARS655101
• Device Lot Number: AZ1322077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1