MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 85/80; NAIL, FIXATION, BONE

Catalog Number	71677085
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had pain and went to the hospital.It was found that the implanted proximal nail and compression screw were broken.
Additional Manufacturer Narrative
The affected lag/compression screw kit and intertan nail were not returned for evaluation.Our investigation included a review of complaint history for the listed parts which revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A clinical evaluation noted that two undated x-rays have been provided and reviewed. the x-rays confirm the presence of the broken nail and proximal screw as well as what appears to be non-union. there is no report of traumatic injury and there are no additional medical documents available for review. additionally, there is no report of the patient's current condition or when the revision will be performed. in the absence of any relevant supporting documentation, a definitive root cause of the reported device fracture cannot be determined.Based on insufficient information, no further clinical assessment can be performed.Without the return of the actual product involved, our investigation of this report is inconclusive.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: LAG/COMP SCREW KIT 85/80
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7653966
• Report Number: 1020279-2018-01260
• Device Sequence Number: 19210574
• Product Code: JDS
• UDI-Device Identifier: 03596010563293
• UDI-Public: 03596010563293
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

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: 71677085
• Device Lot Number: 17GT90549
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/01/2018
• Supplement Report FDA Received Date: 10/06/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR