MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK BROACH

Catalog Number UNK BROACH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); No Code Available (3191)

Event Date 04/01/2020

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

The literature article entitled, "surgical automation reduces operating time while maintaining accuracy for direct anterior total hip arthroplasty" written by aamir a.Bhimania, james m.Rizkallaa, kurt j.Kitzigerb, paul c.Peters jr., richard d.Schubertb, and brian p.Gladnick published by journal of orthopaedics, made available online 1 april 2020, was reviewed.The article's purpose was to study difference between automated versus manual surgical techniques for direct anterior total hip arthroplasty.All patients in the study received depuy products and the kincise system was utilized for the automated group.The article reports only one adverse event for a (b)(6) female with a history of osteoporosis that experienced an intraoperative calcar fracture during broaching.The fracture was treated with two luque wires and convert to a cemented stem due to poor bone quality.Depuy product involved: unknown broach.Adverse event: femoral fracture during broaching (treated by wiring intraoperatively).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the literature article entitled, "surgical automation reduces operating time while maintaining accuracy for direct anterior total hip arthroplasty".The article's purpose was to study the difference between automated versus manual surgical techniques for direct anterior total hip arthroplasty.All patients in the study received depuy products and the kincise system was utilized for the automated group.The article reports only one adverse event for a 72-year-old female with a history of osteoporosis that experienced an intraoperative calcar fracture during broaching.The fracture was treated with two luque wires and convert to a cemented stem due to poor bone quality.The device associated with this report was not returned.A review of the device history records and/or a lot-specific complaint database search was not possible as the product and lot code required was not provided.With no instrument returned and no more information, no root cause can be determined for this specific instrument.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify the root cause, the need for corrective action was not indicated.Complaints will be monitored under post market surveillance sep 419.

• Brand Name: UNK BROACH
• Type of Device: BROACH
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10874720
• MDR Text Key: 217323242
• Report Number: 1818910-2020-25087
• Device Sequence Number: 1
• Product Code: HTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK BROACH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention