MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX38MM NON STERILE; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWJ338
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a screw broke while trying to back it out.It was further reported that broken half of the screw was left implanted.The remaining half was removed and will be returned for investigation.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that a screw broke while trying to back it out.It was further reported that broken half of the screw was left implanted.The remaining half was removed and will be returned for investigation.
Additional Manufacturer Narrative
Please note the correction made to the h6 clinical code: the reported event was confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: a visual inspection found the perform reversed peripheral 5.0mm x 38mm non-sterile screw to be broken.Additionally, the head and threads of the screw show numerous cuts and gouges along multiple surfaces.Only a portion of the screw was returned as the remaining portion was left implanted.A review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation and provided information, the root cause was attributed to a user issue ¿ misuse of the device/failure to follow the surgical technique.The returned device showed signs of intense usage.The hex tip of the screw is stripped, the threads show numerous cuts and gouges along multiple surfaces, and there are signs of a sudden brittle fracture.All these things are evidence enough to suggest intense torsional force was applied to the screw which led to a forced fracture.If any additional information is provided, the investigation will be reassessed.

• Brand Name: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX38MM NON STERILE
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16738475
• Report Number: 0001649390-2023-00050
• Device Sequence Number: 15130911
• Product Code: PHX
• UDI-Device Identifier: 00846832089307
• UDI-Public: 00846832089307
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2026
• Device Model Number: DWJ338
• Device Catalogue Number: DWJ338
• Device Lot Number: CZ1522193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 06/04/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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