MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK BROACH; BROACHES

Catalog Number UNK BROACH

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

Patient Problem Bone Fracture(s) (1870)

Event Date 01/22/2021

Event Type  Injury  

Manufacturer Narrative

(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

Clinical adverse event received for intraoperative right hip small calcar periprosthetic fracture - femoral.Event is serious and is considered mild.Event is possibly related to device and is definitely related to procedure.Patient received a right pinnace/corail cop total hip arthroplasty to treat end-stage osteoarthritis.The sup was placed in anteversion matching the patient¿s anatomy and secured with two dome screws.The patient sustained a small femoral calcar crack during broaching with a size 10 broach which was treated with cerclage wires.The surgeon notes that there was a less than 1mm gap after cerclage but that the stem was rotationally stable.The stem had excellent fit and fill on post implantation fluoroscopy.The patient had excellent stability and rom and leg lengths were acceptable.The procedure was completed without complications.Doi: (b)(6) 2020- primary tka with intraoperative calcar fracture during broaching.Date of implantation: (b)(6) 2021, date of event (onset): (b)(6) 2021, (right hip).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned.A review of the provided x-rays could not confirm the complaint as the only x-rays provided were pre-revision.There were no product allegations against the unknown reamer.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 were 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 (b)(4).

• Brand Name: UNK BROACH
• Type of Device: BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11327307
• MDR Text Key: 240287969
• Report Number: 1818910-2021-02950
• 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,study
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• 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: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALTRX NEUT 32IDX50OD; CORAIL2 NON COL HO SIZE 11; DELTA CER HEAD 12/14 32MM +5; PINN CAN BONE SCREW 6.5MMX15MM; PINN CAN BONE SCREW 6.5MMX20MM; PINNACLE SECTOR II CUP 50MM
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 82