MAUDE Adverse Event Report: TORNIER S.A.S. TORNIER PYROCARBON HUM HEAD DIA 39MMX14MMX3.5MM ECC; SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD/METALLIC STEM CEMENTED

Catalog Number	DWH139
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant was found broken when the box was opened.The low offset version of the same diameter and height with no noted compromise to the fit.
Additional 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.
Event or Problem Description
It was reported that the implant was found broken when the box was opened.The low offset version of the same diameter and height with no noted compromise to the fit.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation.Visual inspection: right half part: a defect (hole) is visible on bottom right, note red marks on top left are just blood left by surgeon¿s gloves.Left half part : defect corresponds exactly with the right part.Fracture is clearly passing in the middle of the defect.The pyrocarbon bearing surface component is fractured in 2 equal parts, fracture pass-ing by the center of the device.The only defect visible on the fracture plane is a cavity in the graphite material, on both halves, matching one with the other.This cavity is ovoid in shape (like a rugby ball) of about 700¿m in length and 500¿m in diameter.Surfaces of this cavity are not regular.This hole is situated in a position, near the inside surface of the morse taper.Functional inspection: due to the nature of the returned device, a functional inspection was not possible.Dimensional inspection: the chromium-cobalt double taper was verified with the 3-dimensional control equipment (ref # (b)(4)) and it was conformed to the specifications.Due to the nature of the returned pyrocarbon head, a dimensional inspection was not possible.Based on investigation, the root cause was attributed to a device material related issue.The event was caused by a cavity on the raw material.The event has been elevated to an nc.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.

• Brand Name: TORNIER PYROCARBON HUM HEAD DIA 39MMX14MMX3.5MM ECC
• Common Device Name: SHOULDER JOINT HUMERAL (HEMI-SHOULDER) CERAMIC HEAD/METALLIC STEM CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17982331
• Report Number: 3000931034-2023-00364
• Device Sequence Number: 11375993
• Product Code: QKW
• UDI-Device Identifier: 03700434019643
• UDI-Public: 03700434019643
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: DEN220012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: DWH139
• Device Lot Number: 6526AZ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 10/22/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown