MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONICAL TAP 7MM; PLATE, FIXATION, BONE

Catalog Number	71369007
Medical Device Problem Codes	Fracture (1260); Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the surgeon broke the tip of the instrument in the femur and was unable to remove it.
Additional Manufacturer Narrative
The associated conical tap was not returned for evaluation.A clinical evaluation noted that all documents provided as of this date have been reviewed and considered and unless noted do not identify a root cause or contribute to the clinical investigation.Therefore based on insufficient relevant information, no further clinical assessment is warranted.Without the return of the actual product involved and no batch information available, 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 devices or additional information be received, the complaint will be reopened.

• Brand Name: CONICAL TAP 7MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7329835
• Report Number: 1020279-2018-00299
• Device Sequence Number: 119457
• Product Code: HRS
• UDI-Device Identifier: 03596010437631
• UDI-Public: 03596010437631
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123055
• 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): 07/05/2018

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: 71369007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/11/2018
• Supplement Report FDA Received Date: 07/09/2018
• 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; Other