MAUDE Adverse Event Report: CORIN MEDICAL TRINITY ACETABULAR HIP SYSTEM; ZIMMER OFFSET REAMER HANDLE

Model Number Z399.110

Device Problems Break (1069); Mechanical Jam (2983); Unintended Movement (3026)

Patient Problems Head Injury (1879); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is being returned and will be reviewed at corin.The appropriate device details have been provided and the relevant device manufacturing records will be identified and reviewed.Details of thse reviews will be provided in a supplemental report upon completion of the investigation.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 distributor caused or contributed to this event.

Event Description

During surgery the inner section of a trinity offset reamer handle broke.The instrument then jammed, kicked back and hit the surgeon in the head.This led to a 20 minute surgical delay and the surgeon had to re-scrub.

Manufacturer Narrative

Per4058 final report the device was returned to corin and the failure mode was confirmed.The appropriate device details were provided, and the relevant device manufacturing records have been identified and reviewed; the device had been in use in the field for approx.Seven and a half years at the time of the reported event.All parts associated with these records conformed to material and dimensional specification at the time of manufacture.This event is considered to be the result of wear and tear through normal intended use.Similar events have been reported in the past.As a result of feedback from the field an internal project was initiated in august 2019 to manufacture these handles with different design and supplier.The reported device was manufactured prior to this change.Corin now considers this case closed.We will continue to monitor feedback for this failure mode.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.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

Trinity offset reamer handle shaft has broken.It jammed during the surgery and hit the surgeon in the head.The surgeon was fine but had to rescrub, causing a surgical delay of 20 mins.

• Brand Name: TRINITY ACETABULAR HIP SYSTEM
• Type of Device: ZIMMER OFFSET REAMER HANDLE
• Manufacturer (Section D): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer (Section G): CORIN MEDICAL; the corinium center; cirencester, GL7 1 YJ; UK GL7 1YJ
• Manufacturer Contact: marie-anne euzen ; the corinium center; cirencester, GL7 1-YJ ; UK GL7 1YJ
• MDR Report Key: 12376449
• MDR Text Key: 271071134
• Report Number: 9614209-2021-00105
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093472
• 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: 01/19/2022

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: Z399.110
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: 064224-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• 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