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

Model Number 580.9410

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No adverse event reported.The appropriate device details have been provided and the relevant device manufacturing records will be retrieved and reviewed.The reported device has been returned to corin and will be examined and information will be provided in a supplemental report upon completion of the investigation.

Event Description

The plactic piece of a minihip stem extractor has broken off the main body of the device.

Manufacturer Narrative

Per -59 final report.This final report is being submitted retrospectively as per fda request.The reported device was returned to corin and reviewed.Damage was observed to the metal shaft of the instrument, indicating extensive use.It was found that the sub component part which had broken, had a different lot code to that of the main body of the device thus meaning that this was not the original sub component part assembled with lot 209332.This device had been disassembled and reassembled with the incorrect sub component, outside of corin.The device manufacturing records for the main body of the instrument and for the sub component part have been identified and reviewed.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.It has been concluded that the reported event is attributable to wear from extensive use and thus corin now consider this case closed.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.

Event Description

The plastic piece of a minihip stem has broken off the main body of the device.

• Brand Name: MINIHIP
• Type of Device: MINIHIP STEM EXTRACTOR
• 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: franck didier ; the corinium centre; cirencester, gloucestershire GL7 1-YJ ; UK GL7 1YJ ; 1285659866
• MDR Report Key: 6093039
• MDR Text Key: 60077138
• Report Number: 9614209-2016-00155
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/25/2023

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 Model Number: 580.9410
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 068578-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/10/2016
• Supplement Dates Manufacturer Received: 10/11/2016
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1