MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 BROACH CORAIL AMT 12; HIP INSTRUMENTS : BROACHES

Model Number L20412

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

Patient Problem Limb Fracture (4518)

Event Date 07/07/2021

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

Post operative x ray showed an trochanteric fracture which was initially treated conservatively but at the two week mark x ray showed migration of the fragment.Patient subsequently taken back to theatre for fixation.Satisfactory result of that surgery thus far.Doi: (b)(6) 2021, unknown hip.

• Brand Name: BROACH CORAIL AMT 12
• Type of Device: HIP INSTRUMENTS : BROACHES
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 12392373
• MDR Text Key: 268946574
• Report Number: 1818910-2021-18989
• Device Sequence Number: 1
• Product Code: HTQ
• UDI-Device Identifier: 10603295258148
• UDI-Public: 10603295258148
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: L20412
• Device Catalogue Number: L20412
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORAIL AMT COLLAR SIZE 12; CORAIL AMT COLLAR SIZE 12
• Patient Outcome(s): Required Intervention