MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T7 DRIVER SHAFT W/AO QC; SCREWDRIVER

Catalog Number	71174927
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the driver tip broke off during surgery and remained inside the patient.No delay reported.An s&n backup was available.

• Brand Name: T7 DRIVER SHAFT W/AO QC
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8976419
• Report Number: 1020279-2019-03310
• Device Sequence Number: 14212898
• Product Code: HXX
• UDI-Device Identifier: 00885556387641
• UDI-Public: 00885556387641
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2019

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 Catalogue Number: 71174927
• Device Lot Number: 14DVP0004
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 09/09/2019
• 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; Required Intervention