MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK BROACH

Catalog Number UNK BROACH

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2021

Event Type  Injury  

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 Description

This complaint is from a literature source.The following literature cite has been reviewed: brzezinski a, mascarenhas d, simon m, kayiaros s.A unique complication of femoral broach fracture and incarceration during total hip arthroplasty.Arthroplast today.2021 aug 21;11:49-53.Doi: 10.1016/j.Artd.2021.07.011.Pmid: 34466637; pmcid: pmc8387731.Objective and methods: the purpose of this article was to present two cases with a unique complication of broach fracture with subsequent incarceration during femoral canal preparation.The authors also sought to describe a minimally invasive technique of broach extraction.Lot, model and catalog number are not available, but the suspected depuy device possibly associated with reported adverse events: actis broach.Adverse event(s) and provided interventions associated with depuy devices: case 1: (b)(6) year-old make patient received a right hip tha to treat pain secondary to osteoarthritis.During femoral preparation, the final broach fractured and became lodged into the femur during attempted extraction.The surgeon then removed the broach by creating a small cortical window in the anteromedial cortex level at the diaphyseal junction using osteotome.The osteotome was then used at a 45-degree angle to extract the broach using a mallet.Once the broach was removed, the definitive actis stem was implanted, and a cortical graft of autologous bone secured by a1.7 mm depuy synthes cable was used to secure the cortical window.The procedure was completed without further complications.There was no fracture of the femur, and the stem was stable.At 3- and 6-months follow-up, the patient had an excellent recovery with an hhs that improved from 38 to 100.Case 1 radiographs pp.51 fig 3 case 2: (b)(6) year-old female received a right actis tha to treat pain secondary to advanced osteoarthritis.During femoral preparation, the final broach fractured and became lodged into the femur during attempted extraction.The surgeon then removed the broach by creating a small cortical window in the anteromedial cortex level at the diaphyseal junction using osteotome.The osteotome was then used at a 45-degree angle to extract the broach using a mallet.Once the broach was removed, the definitive actis stem was implanted, and a cortical graft of autologous bone secured by a1.7 mm depuy synthes cable was used to secure the cortical window.Postoperative radiographs revealed a small minimally displaced fracture at the tip of the greater trochanter with a well aligned stem.The fracture was treated with minimal weight bearing.At four- and six-months follow-up the patient had stopped pt and exhibiting normal pain-free gait with an improved hhs of 92.Case 2 radiographs pp.52 fig 4 and fig 5.

• Brand Name: UNK BROACH
• Type of Device: BROACH
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12666162
• MDR Text Key: 277460779
• Report Number: 1818910-2021-23062
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK BROACH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention