MAUDE Adverse Event Report: JOINT RECON : VIANT MEDICAL (FORMERLY GREATBATCH) PINN GB OFFSET GRATER HANDLE; HANDLES

Model Number	T17653
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the blue handle offset gratebatch reamer was broken.
Additional Manufacturer Narrative
Product complaint (b)(4).Based on further analysis, it was determine, depuy synthes is not the legal manufacturer of the product.The complaint has been forwarded to the supplier for further analysis.

• Brand Name: PINN GB OFFSET GRATER HANDLE
• Common Device Name: HANDLES
• Manufacturer (Section D): JOINT RECON : VIANT MEDICAL (FORMERLY GREATBATCH); 2 hampshire street; foxborough MA 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14084360
• Report Number: 1818910-2022-06598
• Device Sequence Number: 14771298
• Product Code: HTO
• UDI-Device Identifier: 00840096400083
• UDI-Public: 00840096400083
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: T17653
• Device Catalogue Number: 255000100
• Device Lot Number: PC5143527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown