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

Catalog Number UNK_WTB

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 03/24/2023

Event Type  Injury  

Event Description

It was reported that the assembly screw broke in two resulting in a disassembly of proximal and distal part.The patient had to undergo a revision surgery.

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

Manufacturer Narrative

The reported event could be confirmed, since x-rays were provided for evaluation.A review of the x-rays by the medical expert confirmed the alleged failure.The opinion of the medical expert was requested and stated as following: ¿the device was used as indicated.There was however a concession made by the surgeon to make sure that the prosthesis was supported sufficiently by bone circumferentially at the metaphysis-stem junction.The user took a risk leaving the prosthesis unsupported by bone circumferentially at the metaphysis-stem junction.This has put this junction under high stresses and at risk for the reported assembly screw breakage leading to component disassembly.¿ a review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.Based on the available x-ray and formal medical opinion the probable root cause was attributed to be a user related error.If the device is returned or if any additional information is provided, the investigation will be reassessed.¿ h3 other text : device not returned.

Event Description

It was reported that the assembly screw broke in two resulting in a disassembly of proximal and distal part.The patient had to undergo a revision surgery.

• Brand Name: UNKNOWN ASSEMBLY SCREW
• 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: 16791945
• MDR Text Key: 313800604
• Report Number: 0001649390-2023-00070
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose