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

Model Number	71365703
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thr the offset broach handle was not gripping, coming off the broaches when being impacted, nothing fell inside the patient wound.Instruments inside patient.Procedure finished with s&n backup device.Surgical delay of less than or equal to 30 minutes.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device does not confirm the stated failure mode.The device shows extensive wear around the clamping mechanism.The device has nicks and scratches.A functional evaluation of the returned device confirmed the stated failure mode.The device, when mated with the corresponding part, it has some degrees of movement.Though the movement is not a lot, the instrument requires precision.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 do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.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.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.We consider this investigation closed.

• Brand Name: OFFSET BROACH HANDLE
• Common Device Name: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11382440
• Report Number: 1020279-2021-01596
• Device Sequence Number: 4037558
• Product Code: JDG
• UDI-Device Identifier: 03596010553393
• UDI-Public: 03596010553393
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: 71365703
• Device Catalogue Number: 71365703
• Device Lot Number: 15BM11023
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 06/04/2021
• Patient Sequence Number: 1