MAUDE Adverse Event Report: CORIN MEDICAL UNITY TOTAL KNEE SYSTEM; PATELLA DRILL (HUDSON)

Model Number H123.083.50

Device Problems Break (1069); Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Per -(b)(4) initial report.Additional information, including date of event, x-rays, device details, whether the drill was worn, whether surgery was delayed, impact to the patient and return of the part of the drill not left in the patient has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.Upon receipt of the appropriate device details the relevant device manufacturing records will be identified and reviewed.

Event Description

It was identified via a post-operative x-ray that part of a unity patella drill had broken off and was in the patient bone.

Manufacturer Narrative

Per -3906 final report.Additional information, including date of event, x-rays, device details, whether the drill was worn, whether surgery was delayed, impact to the patient and return of the part of the drill not left in the patient has been requested in order to progress with the investigation of this event.However no information was available.Several drills were returned from the hospital but it was not confirmed that the one used during the surgery was among them.The drills relevant manufacturing records were identified and reviewed, and it was found that the devices conformed to material and dimensional specification at the time of manufacturing.Review of the drills showed wear but the deformation was not significant enough to account for the metal fragment found by the surgeon.45 patella drill guides that may have been used with the drill were returned from the hospital.11 of them were identified to have score marks.It is possible that the metal fragment came from the drill guide as the drill rubbed against it but cannot be confirmed as information on the size of the drill guide used during the surgery was not available.Based on the information above, the root cause of the reported event can't be confirmed.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

It was identified via a post-operative x-ray following a surgery involving unity devices and instruments that a metal fragment was in the patient bone.

• Brand Name: UNITY TOTAL KNEE SYSTEM
• Type of Device: PATELLA DRILL (HUDSON)
• 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: 12047572
• MDR Text Key: 257761835
• Report Number: 9614209-2021-00079
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113060
• 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: 04/20/2022

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: H123.083.50
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 45 UNITY PATELLA DRILL GUIDES.
• Patient Outcome(s): Other