MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC UNKNOWN KINCISE ADAPTOR DEVICES; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number UNK-KINCISE-ADAPTORS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/17/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H4: this report is for an unknown adaptor device.Part and lot number are unknown.Without the specific part number, the udi number, 510-k number, and device manufacture date are unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10: concomitant med products: broach device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Note: medwatch report 1818910-2023-18027 as the products were used together in the same event.

Event Description

It was reported that during a total hip replacement surgical procedure, the post of the broach device broke off in the femur during extraction with the adaptor device.It was reported that the post was removed, however bone removal was needed in order to gain access.It was reported that there was a five to ten minute delay in surgery to remove the post.There was patient involvement.It was not reported if prolonged hospitalization was required due to this event.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: UNKNOWN KINCISE ADAPTOR DEVICES
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 17724404
• MDR Text Key: 323124448
• Report Number: 1045834-2023-01267
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-KINCISE-ADAPTORS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male