MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MMX32MM CAPTURED SCREW; SCREW, FIXATION, BONE

Catalog Number	71661232
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a broken imhs-cp nail.No delay or additional injuries reported.Broken nail was replaced with a competitor device.
Additional Manufacturer Narrative
The associated complaint devices were not returned for evaluation.The devices were manufactured in 2013.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.A clinical evaluation noted that the reported painful and debilitating pseudoarthrosis/diagnosed subtrochanteric non-union was the contributing factor to the failed osteosynthesis /im nailing as the hardware is intended only as a temporary support during bony healing and not as a permanent weight-bearing replacement.The causal relationship between the continued non-union and the prosthesis cannot be concluded, although the continued weight-bearing activities in the presence of non-union and the reported history of bisphosphonate therapy for osteoporosis likely contributed to the ongoing issues.The differing medical opinions, diagnoses, and treatment modalities do not reflect a mal-performance of the smith and nephew implants.The patient impact beyond the reported persistent pain and subsequent revisions due to non-union cannot be concluded.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the devices or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: 4.5MMX32MM CAPTURED SCREW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8257064
• Report Number: 1020279-2019-00192
• Device Sequence Number: 1915627
• Product Code: HWC
• UDI-Device Identifier: 03596010518590
• UDI-Public: 03596010518590
• Combination Product (Y/N): N
• PMA/510(K) Number: K040656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2019

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 Expiration Date: 01/15/2023
• Device Catalogue Number: 71661232
• Device Lot Number: 13AM10571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 04/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention