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

Event Date 09/23/2020

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

It was reported that the surgeon was revising a competitor knee with a loose tibia at the cement to implant and bone to cement interfaces.Competitor cement was used.Patient sustained a fracture along the proximal anterior-medial portion of the tibia either during broaching, implant insertion or final implant reduction.Surgeon feels that it is too difficult to broach a tibia for sleeve preparation.The cutting threads are possible not aggressive enough.Radiographs were performed and there did not appear to be any extension beyond the proximal portion of the sleeve.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary - no device was received for examination, therefore the reported event could not be confirmed.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.H10 additional narrative: added: d11.

• 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: 10661596
• MDR Text Key: 211128687
• Report Number: 1818910-2020-21900
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• 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: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN KNEE TIBIAL TRAY.
• Patient Outcome(s): Required Intervention