MAUDE Adverse Event Report: EXACTECH, INC. RTSA REDUCTION TOOL; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number RTSA REDUCTION TOOL

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2023

Event Type  Injury  

Manufacturer Narrative

Additional information, including the product investigation, will be submitted within 30 days of receipt.

Event Description

As reported during surgical use, the tip of skid broke off while reducing shoulder.Piece was not confirmed in patient or on ground.Never found.X-ray was taken but not received, images received.X-rays requested.The device is available for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the broken rtsa reduction tool reported may have been the result of applying a bending moment to the device while reducing the shoulder, which led to crack initiation, propagation, and ultimate fracture at the tip.The most probable root cause associated with the reported event of ¿broken - minor surgical delay¿ is associated with a partial or full-thickness crack in the device materials.

• Brand Name: RTSA REDUCTION TOOL
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 16443759
• MDR Text Key: 310252569
• Report Number: 1038671-2023-00239
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862558541
• UDI-Public: 10885862558541
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RTSA REDUCTION TOOL
• Device Catalogue Number: 321-19-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male