MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED CTR SCREW 6.5MMX30MM STERILE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWJ530
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales rep reported, "following a problem with the dmi shoulder prosthesis at the hospital, the broken screw and the glenosphere screw were noted intraoperatively." in addition, the customer reported, "mobilization of glenosphere plate + functional degradation following a fall in (b)(6) 2022- 1 broken screw glenosphere screw broken in central screw difficulty in extracting broken screw fragment, preventing extraction of plate fragment extracted using microsurgical forceps".Patient also required antibio-therapy due to the revision surgery.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
Correction - please refer to g1 manufacturing site for devices, h6 (device, clinical codes).After through investigation and review of images received, this device, catalog # dwj530 was found to not have been broken.Therefore, this device is now deemed concomitant as it did not contribute to the reported failure.Therefore, this complaint is closed without further investigation and mfr report # 0001649390-2024-00048 is to be cancelled.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.
Event or Problem Description
The sales rep reported, "following a problem with the dmi shoulder prosthesis at the hospital, the broken screw and the glenosphere screw were noted intraoperatively." in addition, the customer reported, "mobilization of glenosphere plate + functional degradation following a fall in (b)(6) 2022- 1 broken screw glenosphere screw broken in central screw difficulty in extracting broken screw fragment, preventing extraction of plate fragment extracted using microsurgical forceps".Patient also required antibio-therapy due to the revision surgery.

• Brand Name: TORNIER PERFORM REVERSED CTR SCREW 6.5MMX30MM STERILE
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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 MN NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18691903
• Report Number: 0001649390-2024-00048
• Device Sequence Number: 8518470
• Product Code: KWS
• UDI-Device Identifier: 00846832091102
• UDI-Public: 00846832091102
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: DWJ530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG