MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. NONRIM SPEED PIN 65 STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	74013480
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip of speed pin (5mm from tip) broke and remained in femoral.It was found during x-ray check immediate post-operation.The surgeon decided that broken tip left in patient because it was located difficult region.
Additional Manufacturer Narrative
The affected 6.5 mm non rimmed threaded speed pin was not returned for evaluation.However, a picture was provided.Visual inspection of the photo confirmed the tip of pin has broken off.Our investigation included a review of complaint history did not reveal additional complaints for this failure mode.A review of the manufacturing records for the listed batch which did not reveal any deviation from the standard manufacturing processes.A clinical evaluation noted that no relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a clinical assessment cannot be performed at this time.Our investigation could not determine a specific cause of the failure.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: NONRIM SPEED PIN 65 STERILE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH AND NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7799518
• Report Number: 1020279-2018-01547
• Device Sequence Number: 2507452
• Product Code: HSX
• UDI-Device Identifier: 00885556070925
• UDI-Public: 00885556070925
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2018
• Device Catalogue Number: 74013480
• Device Lot Number: 17ENX0024
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR