MAUDE Adverse Event Report: JOINT RECON : VIANT MEDICAL (FORMERLY GREATBATCH) XBACK GB ACE GRATER 48MM; HIP INSTRUMENTS : REAMERS

Catalog Number	255000048
Medical Device Problem Codes	Failure to Cut (2587); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that reamer is dull.Patient status/ outcome / consequences --> no patient involvement, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none, (b)(6) device property of -->none, device in possession of -->none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.
Additional Manufacturer Narrative
Product complaint # = > (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: an analysis of the product could not be performed, since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed, as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected and distributed to approved specifications.Additional complaint information, monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: h6 medical device problem code if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2a, d3 manufacturer ( address street line 1, city, state code, zip code), d4 ( catalog, udi), g1 manufacturer (facility name, addr.Street line 1, city, state code, zip code).

• Brand Name: XBACK GB ACE GRATER 48MM
• Common Device Name: HIP INSTRUMENTS : REAMERS
• Manufacturer (Section D): JOINT RECON : VIANT MEDICAL (FORMERLY GREATBATCH); 2 hampshire street; foxborough MA 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 4545 kroemer road; fort wayne IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18480971
• Report Number: 1818910-2024-00707
• Device Sequence Number: 6398798
• Product Code: HTO
• UDI-Device Identifier: 00840096400557
• UDI-Public: 00840096400557
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup,Followup
• Report Date (Section B): 01/09/2024

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 Catalogue Number: 255000048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 02/15/2024; 03/20/2024; 03/20/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/15/2024; 03/21/2024; 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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