MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SYN F/T BRCH SZ 16; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71366716

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2018

Event Type  Injury  

Event Description

It was reported that a medical intervention was required due to 16 broach (7136-6716, 14fm18758) shred off the broach during hip replacement with high offset trial neck 7136-6514, 14gm06585.Dr performed osteotomy to remove the broach successfully.There was 40 minute delay reported.

Manufacturer Narrative

The associated synergy broach was returned.The trial neck was not returned for evaluation.A visual inspection of the returned product confirms the stated failure.The post has fractured off of the broach, the broken piece is also returned with the complaint.This broach was manufactured in 2014 and it exhibits signs of significant use and wear.A review of complaint history of both devices revealed no additional complaints for the listed batches with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A clinical evaluation noted that the surgeon believes that the leverage placed on the broach while backing out caused a stress fracture on the post.Although an osteotomy was reportedly required to remove the broach after the stem sheared, the right tha was successfully completed within a 40 minute surgical extension.The provided images did not provide insight to the cause of the reported event, and due to the poor quality and single view, the extent of the reported osteotomy cannot be concluded.No further patient impact is expected beyond the reported osteotomy and subsequent surgical delay, as there was reportedly no injury and the patient was ¿doing fine¿.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: SYN F/T BRCH SZ 16
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7851908
• MDR Text Key: 119405387
• Report Number: 1020279-2018-01734
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010429698
• UDI-Public: 03596010429698
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

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 Catalogue Number: 71366716
• Device Lot Number: 14FM18758
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/14/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 08/14/2018
• Supplement Dates FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention