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

Catalog Number UNK-ATTACHMENTS

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

Patient Problem Bone Fracture(s) (1870)

Event Date 12/14/2018

Event Type  Injury  

Manufacturer Narrative

Of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If additional information should become available, a supplemental medwatch report will be sent accordingly.

Event Description

It was reported that during an unspecified surgical procedure, while using the kincise power broach system, the "fem" was fractured during sequential broaching.It was further reported that the fracture occurred at the distal tip of the #6 broach.It was reported that the broach was removed and a long stem was implanted.It was reported that there was a 45 minute delay in the surgical procedure.It was not reported whether a spare device was available for use.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Corrected data: the is adverse event field was inadvertently left unchecked in the initial medwatch.The field has been updated to reflect an adverse event.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional information: upon subsequent follow-up with the reporter, additional information was received.Following patient information was received and applicable fields have been updated in the medwatch.Patient initials: (b)(6), age: (b)(6), gender: female.It was reported that the while sequentially broaching the femur, a femoral fracture occurred when the #6 broach was put down the femur.The broach was removed intact.It further reported that it was the bone that fractured, not the associated device.The procedure was completed successfully using a long stem device.It was reported that event occurred during a total hip replacement surgical procedure.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN ATTACHMENTS
• 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): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC 29625
• Manufacturer Contact: kara ditty-bovard ; 4500 riverside drive; palm beach gardens, FL 33410 ; 6103142063
• MDR Report Key: 8241862
• MDR Text Key: 132905099
• Report Number: 1045834-2019-52578
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-ATTACHMENTS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 01/23/2019; 03/05/2019
• Supplement Dates FDA Received: 02/08/2019; 03/06/2019
• 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 Age: 68 YR