MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 90/85; NAIL, FIXATION, BONE

Model Number	71677090
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the compression screw did not enter the brocade guide and showed rebound to enter the sliding screw.At the end, no compression screw is placed, distal locking was not performed, nail insertion arch was removed, the sliding screw blocked and 0 mm plug placement was performed, which also does not fit properly into the intertan intramedullary nail.No injury reported.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch numbers.Factors and/or potential probable causes that could contribute to the reported event have been identified in the risk management file, possible as tolerance stack up, part geometry, over-use, excessive force applied, use of older model guides/sleeves, and geometry allows drill to drill deeper than intended.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LAG/COMP SCREW KIT 90/85
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9528704
• Report Number: 1020279-2019-04616
• Device Sequence Number: 11557264
• Product Code: JDS
• UDI-Device Identifier: 03596010563309
• UDI-Public: 03596010563309
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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 Model Number: 71677090
• Device Catalogue Number: 71677090
• Device Lot Number: 19DM15808
• Initial Date Received by Manufacturer: 12/01/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 12/29/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1