MAUDE Adverse Event Report: CORIN MEDICAL MINIHIP; CORIN MINIHIP STEM

Model Number 580.9410

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No adverse event reported.The relevant device details have been provided and the relevant device manufacturing records will be retrieved and reviewed.The device has been requested to be returned to corin (b)(4) for examination, and if received, it will be reviewed and information supplied in a supplemental report upon completion of the investigation.Please note: this report is filed with the fda due to an 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 plastic end of a minihip stem extractor has broken and come off the main body of the device.

Manufacturer Narrative

(b)(4) final report.No adverse event reported.The device manufacturing record for this instrument was identified and reviewed.This instrument was manufactured in 2012 as part of a batch of 2: the instruments were manufactured in accordance with specification.This instrument was in use for approximately 4 years.Surgical instruments are subject to wear with normal usage and instruments which have experienced extensive use are susceptible to fracture.It was concluded following our investigation that the damage observed to the instrument was consistent with intended use.Please note: this report is filed with the fda due to an 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 plastic end of a minihip stem extractor has broken and come off the main body of the device.

• Brand Name: MINIHIP
• Type of Device: CORIN MINIHIP STEM
• Manufacturer (Section D): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium centre; cirencester, gloucestershire GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: lucinda gerber ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 5846172
• MDR Text Key: 51168174
• Report Number: 9614209-2016-00131
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 580.9410
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 240217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2016
• Initial Date FDA Received: 08/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1