MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG SCREW LENGTH GAUGE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71674058
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the subtrochanteric screw broke while being compressed.It is unknown if there was a backup device or a delay.
Additional Manufacturer Narrative
The associated complaint device was not returned.The failure could not be confirmed by the pictures provided.A review of the manufacturing records for the listed batch did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: LAG SCREW LENGTH GAUGE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8468057
• Report Number: 1020279-2019-01276
• Device Sequence Number: 1920325
• Product Code: HSB
• UDI-Device Identifier: 03596010560568
• UDI-Public: 03596010560568
• Combination Product (Y/N): N
• PMA/510(K) Number: K122170
• 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): 09/26/2019

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: 71674058
• Device Lot Number: 18BSP0003
• Initial Date Received by Manufacturer: 03/07/2019
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/31/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1