MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM S-T CRTX LCK SCRW 85MM; PLATE, FIXATION, BONE

Catalog Number	71807085
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hematoma (1884); Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent on (b)(6) 2018 orif procedure due to treat a right femoral shaft fracture with an intramedullary device and distal plate.The devices used were a trigen femoral nailing system and a periloc plating system.On (b)(6) 2019, the patient reported swelling of the knee and radiology results indicated partial backing out of medial to lateral distal interlocking screw in nail and breakage of most proximal of the distal interlocking screws in nail.On (b)(6) 2019, radiology results indicated breakage of most distal screw in plate.On (b)(6) 2019, non union of the fracture was diagnosed.On (b)(6) 2020, swelling continued and a hematoma was detected.Radiology results indicated complete backing out of lateral to medial screw in nail with head of screw just under the skin.On this same day, the prominent screw was extracted under local anesthesia.Overall, alignment was maintained with callus formation, but healing was not complete (nonunion).The screw was removed.The current state of health of the patient is unknown.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known, and it is not possible to collect it.We do not have the opportunity to identify individual hcps and revisit negative feedback to retrieve further information.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication identified through the review of clinical evidence from post market clinical data collection activities that includes reference to the use of a smith+nephew product.The reported issue(s) relate to known inherent procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to confirm a relationship between the reported event and the device or identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.

• Brand Name: 4.5MM S-T CRTX LCK SCRW 85MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20058965
• Report Number: 1020279-2024-01662
• Device Sequence Number: 7635457
• Product Code: HRS
• UDI-Device Identifier: 03596010522894
• UDI-Public: 3596010522894
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K210837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2024

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?: Yes
• Device Catalogue Number: 71807085
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Female