MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL IMPL; NAIL, FIXATION, BONE, METALLIC

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 05/01/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).Article cite: yapici, f., üçpunar, h., gür, v., onaç, o., alpay, y., karaköse, r., & çamurcu, y.(2022).Functional and radiological comparison of three cephalomedullary nails with different designs used in the treatment of unstable intertrochanteric femur fractures of elderly.Yaslilarda instabil intertrokanterik femur kiriklarinin tedavisinde kullanilan dizaynlari farkli üç sefalomedüller çivinin fonksiyonel ve radyolojik açidan karsilastirilmasi.Ulusal travma ve acil cerrahi dergisi = turkish journal of trauma & emergency surgery : tjtes, 28(5), 668¿677.Https://doi.Org/10.14744/tjtes.2020.80733.

Event Description

On the on the literature review "functional and radiological comparison of three cephalomedullary nails with different designs used in the treatment of unstable intertrochanteric femur fractures of elderly", it was reported that, after undergoing a primary internal fixation with an intertan nailing system, two (2) patients suffered from a deep infection with a sinus tract.The infections were resolved with nail removal and debridement with antibiotic spacer implementation.The outcome of the patient is unknown.Upon an update from the author, it was stated that these deep infections were not implant-related; instead, they were caused by air filtration malfunction.At the beginning of (b)(6) 2022, it was discovered that there was a temporary malfunction with the air filtration system of the operating rooms.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the alleged deep infections that were reported in 2 patients after having an internal fixation procedure using the trigen intertan were not implant or procedure related.The author of the study confirmed that the infections were caused by air filtration malfunction.It was determined that this case does not meet the threshold for reporting and is a non-reportable event pursuant to 21 cfr §803.

• Brand Name: UNKN TRIGEN INTERTAN INTERTROCH ANTEGR NAIL IMPL
• Type of Device: NAIL, FIXATION, BONE, METALLIC
• 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: 15237101
• MDR Text Key: 298023312
• Report Number: 1020279-2022-03672
• Device Sequence Number: 1
• Product Code: NDH
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• 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: 08/22/2022
• 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): Hospitalization; Required Intervention