MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED SCREW 95MM 6.5; PLATE, FIXATION, BONE

Catalog Number	121639
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a surgery to remove the two screws for unspecified reasons.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A clinical analysis indicates that it was reported by the patient that he had two screws removed for unspecified reasons.Patient indicated that there was no problem with the screws, however was very reluctant to provide further information about the surgeon or hospital.The patient provided lot numbers for the revised screws.Based on insufficient information, no clinical assessment is able to be performed.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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.We consider this investigation closed.

• Brand Name: CANNULATED SCREW 95MM 6.5
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7122261
• Report Number: 1020279-2017-01266
• Device Sequence Number: 2037410
• Product Code: HRS
• UDI-Device Identifier: 03596010063946
• UDI-Public: 03596010063946
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K993106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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 Catalogue Number: 121639
• Device Lot Number: 2B09988
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 121640/2B05849
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention