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 Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/24/2019

Event Type  Injury  

Event Description

It was reported that during a thr, the size 16 broach connector broke while the surgeon was trying to take out the broach stem after trailing.The piece that connects to the broach handle broke off and the broach stem remained in the patient¿s femur.The surgeon was able to make a small incision and remove the broach stem with a bone hook.There was a delay reported of 10 min.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The connection post on the device fractured off and was not returned.The device was manufactured in 2001 and exhibits signs of extensive wear / usage.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The medical investigation concluded that, per product evaluation, the approximately 18-year-old device exhibits signs of extensive wear / usage.It was communicated that the broach stem was removed in its entirety, within a 10-15 minute surgical extension, with no harm to the patient, and a ¿good outcome with the surgery¿.No patient harm resulted and no foreign body was retained; therefore, no further medical assessment is warranted at this time.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• 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: 9216088
• MDR Text Key: 163114132
• Report Number: 1020279-2019-03699
• 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: 10/24/2019

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 Expiration Date: 03/13/2011
• Device Catalogue Number: 71366716
• Device Lot Number: 01BM07330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 09/24/2019
• Supplement Dates FDA Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention