MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA & EXTREMITIES DEVICE; NAIL, FIXATION, BONE

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Impaired Healing (2378)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).Abalkhail, t.B., elhessy, a.H., & conway, j.D.(2022).Removal of antibiotic cement-coated interlocking nails.Journal of orthopaedic trauma, 36(6), 317-320.Doi: 10.1097/bot.0000000000002287.

Event Description

It was reported that on literature review "removal of antibiotic cement-coated interlocking nails", one (1) patient suffered from failed bone transport over nail and was indicated for removal or exchange of the interlocking nailing system.The primary trigen interlocking nailing system was implanted with a coating of antibiotic cement and the potential to be permanent (off-label use of the implant).The current state of health of the patient is unknown.No further information is available.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, the attached literature review on "removal of antibiotic cement-coated interlocking nails", was reviewed.However, based on the information provided, no further information is available.Consequently, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The photos provided in the article have been interpreted within the text; therefore, no further analysis of the photos are required.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event have been identified as excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues, patient condition, and/or user error.The contribution of the device to the reported event could not be corroborated.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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRAUMA & EXTREMITIES DEVICE
• Type of Device: NAIL, 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: 15210376
• MDR Text Key: 297702869
• Report Number: 1020279-2022-03632
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention