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

Catalog Number	DWJ338
Medical Device Problem Codes	Break (1069); Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
The primary reverse procedure employed tornier implants, including the shoulder id baseplate and perform humeral.The observed baseplate failure is attributed to likely over-lateralization, stemming from the thickness of the shoulder id baseplate and a lateralized glenosphere.The screw also had a breakage.
Additional Manufacturer Narrative
The reported event of implant migration and screw breakage can be confirmed could be confirmed since x-rays were provided.A device inspection was not possible since the affected device was not returned.Since x-rays were provided, the opinion of the medical expert was requested and stated as following: whether the implant was correctly planned and correctly implanted cannot be assessed from the x-ray showing the implant migration alone.The event of implant migration and screw breakage can be confirmed.Screw breakage is secondary to implant migration and not a root cause.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The primary reverse procedure employed tornier implants, including the shoulder id baseplate and perform humeral.The observed baseplate failure is attributed to likely over-lateralization, stemming from the thickness of the shoulder id baseplate and a lateralized glenosphere.The screw also had a breakage.

• 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: 19328764
• Report Number: 0001649390-2024-00234
• Device Sequence Number: 20560698
• Product Code: PHX
• UDI-Device Identifier: 00846832089307
• UDI-Public: 00846832089307
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWJ338
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male