MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BROACH HANDLE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71364007

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during a thr surgery, a broach handle does not hold the grip.Surgery was completed with a backup device, after a delay greater than 30 mins.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

Section: h3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned broach handle confirms the device exhibit sings of extreme use and wear.The broach handle body has multiple gouges and burrs in the metal.The locking mechanism is damaged as well.A functional evaluation confirms with all visual issues found, the device will not mate with any other device.A review of complaint history for the listed part revealed no prior complaints for the listed batch.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: BROACH HANDLE
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin; austin, TX 78735 ; 5123913905
• MDR Report Key: 12828216
• MDR Text Key: 280880381
• Report Number: 1020279-2021-08204
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010199232
• UDI-Public: 03596010199232
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2014
• Device Model Number: 71364007
• Device Catalogue Number: 71364007
• Device Lot Number: 04AM01917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1