MAUDE Adverse Event Report: CORIN MEDICAL METAFIX; FEMORAL BROACH,

Model Number NOT PROVIDED

Device Problems Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

Per -(b)(4) initial report the appropriate device details have been requested, and if received, the relevant device manufacturing records will be identified and reviewed.Details of this review will be provided in a supplemental report upon completion of the investigation.Return of the reported devices has been requested, and if received will be reviewed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.

Event Description

The size 3 metafix broach got stuck in the patient's femur.There was a struggle to remove it which took 45 minutes.The surgeon had to revert to a cemented option.

Manufacturer Narrative

(b)(4) final report.The stem broach size 3 was not available to be returned and the stem broach details were requested but were reported as not being available.As a consequence, the associated manufacturing records could not be identified.It was reported that the patient was doing well post-surgery.It was also explained that the 2 handles which could have been used for the extraction of the metafix broach ended up on the floor during the surgery.Therefore, the surgeon representative was required to drive to another hospital to retrieve another instrument kit to complete the case.This caused the 45-min intra-operative delay.No further investigation for this event is possible at this time as no devices and insufficient information were provided.If additional relevant information becomes available to indicate further evaluation is warranted, this record will be reopened.Thus, this case is now considered closed.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distrubutor caused or contributed to this event.

Event Description

The size 3 metafix broach got stuck in the patient's femur.There was a struggle to remove it which took 45 minutes.The surgeon had to revert to a cemented option.

• Brand Name: METAFIX
• Type of Device: FEMORAL BROACH,
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, gl7 1yj GL7 1 YJ; UK GL7 1YJ
• MDR Report Key: 10763151
• MDR Text Key: 213894397
• Report Number: 9614209-2020-00098
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: K082525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT PROVIDED
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR