MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RDUCE FRCP W/RCHT BOWED {} 205MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	71173370
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during intramedullary tibia nailing procedure the tip of the forceps was found to be bent out of alignment.A competitor backup was used to complete the procedure.Delay reported was less than 5 minutes.
Additional Manufacturer Narrative
The associated complaint device was not returned.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: RDUCE FRCP W/RCHT BOWED {} 205MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9234625
• Report Number: 1020279-2019-03723
• Device Sequence Number: 344121
• Product Code: JDI
• UDI-Device Identifier: 03596010519511
• UDI-Public: 03596010519511
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2019

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: 71173370
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1