MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIAL 20 DEG 28MM 46-48 OD; PROST,HIP,SEMICONSTRAINED,METALPOLYMER,CEMENT

Catalog Number	71362846
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the instrument broke at the end of the procedure at the extreme, and was in contact with the patient.The surgery was still successfully completed without patient damage.No delay or injury reported.
Additional Manufacturer Narrative
The associated complaint device was not returned.A visual inspection of the photo that was provided confirmed the stated failure mode.The device was heavily damaged where the screw and clip mate with the device causing it to disassemble and not function as intended.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: TRIAL 20 DEG 28MM 46-48 OD
• Common Device Name: PROST,HIP,SEMICONSTRAINED,METALPOLYMER,CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9319015
• Report Number: 1020279-2019-04038
• Device Sequence Number: 2131885
• Product Code: JDI
• UDI-Device Identifier: 03596010455291
• UDI-Public: 03596010455291
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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 Catalogue Number: 71362846
• Device Lot Number: 16GM04478
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1