MAUDE Adverse Event Report: TORNIER INC PM PRIMARY REVERSED BASEPLATE (25MM POST, CENTERED), 25MM; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWJ603
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Nerve Damage (1979); Paralysis (1997); Loss of Range of Motion (2032)
Date of Event	12/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was seen on for standard of care follow-up visit.The treating surgeon did not feel a strong contraction in the axillary nerve.Patient could not hold arm in abduction against gravity.Deltoid contraction was minimal.Patient will complete normal physical therapy plan.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.Device remains implanted in patient.
Event or Problem Description
It was reported the patient was seen on for standard of care follow-up visit.The treating surgeon did not feel a strong contraction in the axillary nerve.Patient could not hold arm in abduction against gravity.Deltoid contraction was minimal.Patient will complete normal physical therapy plan.
Additional Manufacturer Narrative
The reported event could be not be confirmed.The device remains implanted and no other evidences were provided that could confirm the allegation.The opinion of the medical expert was requested and stated as following: ¿this axillary nerve dysfunction, that leads to a deltoid muscle weakness is indeed an ae that is not device related yet related to the surgery.Usually it¿s neuropraxia (traction injury without loss of structural nerve continuity) and will resolve spontaneously, but sometimes it doesn't, or it doesn¿t completely when the nerve is damaged more severely.It will become clear during follow up.Sometimes electrophysiological investigation, assessing the conduction velocity of the nerve(s) at 6 weeks after the problem started, may provide a recovery prognosis.¿ a device inspection was not possible since the affected device was not returned as it remains implanted in the patient.A review of the labeling and the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.If any additional information is provided, the investigation will be reassessed.

• Brand Name: PM PRIMARY REVERSED BASEPLATE (25MM POST, CENTERED), 25MM
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 16210401
• Report Number: 0001649390-2023-00014
• Device Sequence Number: 4370242
• Product Code: PHX
• UDI-Device Identifier: 00846832079483
• UDI-Public: 00846832079483
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K211359
• 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): 04/18/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/16/2023
• Device Model Number: DWJ603
• Device Catalogue Number: DWJ603
• Device Lot Number: 0C0R08O
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 01/19/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown