MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKNOWN; PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL

Model Number	72202042
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke during the procedure.All the pieces were removed from the patient.It is unknown if there was a delay or back up available to complete the procedure.No patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Initial reporters, address line1: (b)(6).
Additional Manufacturer Narrative
H10: h3, h6: the reported knife rasp, intended for use in treatment, was not be returned for evaluation.Without the reported product a visual and functional evaluation cannot be performed and the customer¿s complaint cannot be confirmed.The information provided, ¿the device broke during use¿.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force applied during use.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.
Additional Manufacturer Narrative
H10 h2, h11: additional and corrected information on d4.
Additional Manufacturer Narrative
H3,h6: one 72201661 elite premium rasp knife used for treatment but was not returned for evaluation.This is a four year old reusable instrument.Ifu confirms instructions, precautionary statements and recommendations for proper use of product.Pressure or excess torque was applied causing bending and bowing of the paddle arm.The arm eventually snapped off where it meets the handle.Instrument tips may inadvertently be twisted or caught on other instruments or the basket during cleaning.This can lead to compromised strength.Per ifu 1060355: ¿these instruments are designed for repeated use with proper care and handling.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in the instrument¿s failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges.¿.

• Brand Name: UNKNOWN
• Common Device Name: PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9772825
• Report Number: 3003604053-2020-00007
• Device Sequence Number: 3267598
• Product Code: JDH
• UDI-Device Identifier: 03596010621801
• UDI-Public: 03596010621801
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/19/2020

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: 72202042
• Device Catalogue Number: 72201661
• Device Lot Number: 1612300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 04/03/2020; 04/17/2020; 04/17/2020; 05/18/2020
• Initial Report FDA Received Date: 03/01/2020
• Supplement Report FDA Received Date: 04/08/2020; 04/20/2020; 05/03/2020; 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR