MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 100/95; NAIL, FIXATION, BONE

Model Number	71677100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the item broke at the point of the lag/compression screw combo.It broke inside the patient, and all pieces were recovered.Back-up used to complete the procedure.No delay or injury reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection was performed and confirmed that the intertan nail fractured by the initiation and subsequent propagation of shear forces.The fracture likely initiated on the lateral side of the nail through the proximal hole.The shear forces quickly propagated in a quasi-static manner to an extent that the cross-sectional area of the nail could not bear the imposed loading, which led to an overload fracture of the nail.No material deviations were found during this investigation.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 probable causes that could contribute to the reported event have been identified in the risk management file, such as fracture.Based on this investigation, the need for corrective action is not indicated.Should 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 100/95
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9318096
• Report Number: 1020279-2019-04013
• Device Sequence Number: 467995
• Product Code: JDS
• UDI-Device Identifier: 03596010563323
• UDI-Public: 03596010563323
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 71677100
• Device Catalogue Number: 71677100
• Device Lot Number: 19DT19545
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1