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

Catalog Number 71935642

Device Problems Break (1069); Mechanical Jam (2983)

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

Event Date 08/04/2021

Event Type  malfunction  

Event Description

It was reported that one double offset broach handle right is broken.It is unknown whether this problem was noticed before, during or after the thr surgery.Therefore, patient involvement has not been confirmed.

Event Description

It was reported that during a thr surgery, one double offset broach handle right was tough to open while the broach was loaded.Surgery was resumed with a smith and nephew backup device, no delay was reported.Therefore, no patient injury occurred.

Manufacturer Narrative

G3, h2, h3, and h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The locking mechanism of the device has seized, rendering the device inoperable.The device shows signs of extensive use.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history did not reveal additional complaints for the listed batch for the same failure mode.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and 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.B5: update summary.D8 and d9: device returned.G2: report source update.G4: add 510k code.H6: code update.

• Brand Name: DOUBLE OFFSET BROACH HANDLE RIGHT
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12332823
• MDR Text Key: 266940658
• Report Number: 1020279-2021-06429
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 00885556717424
• UDI-Public: 885556717424
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71935642
• Device Lot Number: 19CDN0497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 08/27/2021
• Supplement Dates FDA Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1