MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 7/16 GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71674071
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the guide bolt wrench head snapped off inside the guide bolt.All pieces accounted for.Delay of over 2 hours reported.No injury reported.Procedure finished with competitor device.
Additional Manufacturer Narrative
The associated guide bolt and guide bolt wrench were returned and evaluated.A visual inspection found that the hex head of the wrench has sheared off; the broken piece was returned with the device.The hex feature can break if the torque applied to the driver exceeds the material strength.The device was manufactured in 2007.The guide bolt was stuck inside the drill guide and could not be removed.The date of manufacture is unknown for this part.Our investigation did not determine a specific cause of the stated failure.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: 7/16 GUIDE BOLT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8104357
• Report Number: 1020279-2018-02595
• Device Sequence Number: 1190955
• Product Code: HSB
• UDI-Device Identifier: 03596010560643
• UDI-Public: 03596010560643
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K122170
• 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,Followup
• Report Date (Section B): 01/25/2019

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: 71674071
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1