MAUDE Adverse Event Report: TORNIER INC PERFORM REV INSERT SZ 3/4, 39MM DIA, +0; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DWP2390
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	02/05/2023
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.H3 other text : device disposition is unknown.
Event or Problem Description
It was reported that a patient had a scapular fracture.Patient experienced shoulder pain.Patient contacted surgeon and was instructed to go to er for x-rays.No fracture readily evident.Patient returned to clinic for soc and study visit.Radiographs clearly showed acromial stress fracture without angulation nor displacement of the fracture.The acromial stress fracture is healing well.
Additional Manufacturer Narrative
The reported event was confirmed, since the medical expert confirmed that the xray provided matches the alleged failure mode.The device inspection was not possible as the product was not returned for investigation.A review of 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.A review of the labeling did not indicate any abnormalities.Formal medical opinion was sought from an experienced independent medical expert as below.¿the original study x-rays confirms the presence of a non-dislocated stress fracture the acromion.And on implant positioning, the implant is well positioned.¿ however, there are several other patient & user related factors that may contribute to acromial stress fractures in rsa, like altered biomechanics, improper surgical technique, poor bone quality, overuse or excessive load, inadequate healing time etc.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that a patient had a scapular fracture.Patient experienced shoulder pain.Patient contacted surgeon and was instructed to go to er for x-rays.No fracture readily evident.Patient returned to clinic for soc and study visit.Radiographs clearly showed acromial stress fracture without angulation nor displacement of the fracture.The acromial stress fracture is healing well.

• Brand Name: PERFORM REV INSERT SZ 3/4, 39MM DIA, +0
• 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: 17305107
• Report Number: 0001649390-2023-00163
• Device Sequence Number: 6684912
• Product Code: PHX
• UDI-Device Identifier: 00846832084487
• UDI-Public: 00846832084487
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K201315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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 Model Number: DWP2390
• Device Catalogue Number: DWP2390
• Device Lot Number: CZ4221302026
• 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: 06/15/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• 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