MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX38MM STERILE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	DWJ738
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
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
Please note correction to g1 (manufacturing site for devices).The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device shows significant signs of implantation as evident by surface appearance.The peripheral screw has breakage near the tip, other half of the screw is not available for inspection.The breakage pattern indicates it to be ductile fracture as indicated by rough surface and severe deformation.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, design & manufacturing related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to patient related issue as the patient had a fall which results into putting excessive pressure or stress on the implant, ultimately leading to its breakage.If any further information is provided, the complaint report will be updated.
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 PERIP SCREW 5.0MMX38MM 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: 18691904
• Report Number: 0001649390-2024-00047
• Device Sequence Number: 20961953
• Product Code: KWS
• UDI-Device Identifier: 00846832091270
• UDI-Public: 00846832091270
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161742
• 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): 06/18/2024

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 Expiration Date: 11/28/2024
• Device Catalogue Number: DWJ738
• Device Lot Number: AC7388
• 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: 05/22/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2019
• 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