MAUDE Adverse Event Report: TORNIER INC TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX50MM STERILE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number DWJ750

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.

Event Description

As reported by the rep: "broken screw head which occurred during the procedure today on final tightening of the peripheral screw.During implantation of the screw.Surgery continued, no loss in stability of implant at the point of surgery".

Manufacturer Narrative

Please note correction to g1 (manufacturing site).The reported event could be confirmed, based on the images provided by third party/user.The device inspection revealed the following: in visual inspection of the provided pictures, it was observed that the screw is broken into pieces and the breakage is near to the tip area, which could be resulted due to an application of excessive mechanical force during use.Furthermore, investigation is not possible as the device is not returned and discarded by the hospital facility.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 labelling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by an application of excessive mechanical force during use.If any further information is provided, the complaint report will be updated.

Event Description

As reported by the rep: "broken screw head which occurred during the procedure today on final tightening of the peripheral screw.During implantation of the screw.Surgery continued, no loss in stability of implant at the point of surgery.".

• Brand Name: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX50MM STERILE
• Type of Device: 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: 18440042
• MDR Text Key: 332618829
• Report Number: 0001649390-2024-00004
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00846832091300
• UDI-Public: 00846832091300
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DWJ750
• Device Lot Number: AC9896
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1