MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN TAYLOR SPATIAL FRAME EXFIX DEV; PIN, FIXATION, THREADED

Catalog Number UNKNOWN

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was documented on the paper that the taylor spatial frame (tsf) (smith & nephew) was applied to 1 patient, post-removal (tsf) refracture reported.This complications was treat with medical intervention (open reduction and internal fixationl).

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, this case reports that a 25 year older who was treated after sustaining multiple gunshot wounds.Some of the injuries included an open pubic ramus fracture, open comminuted fractures of the right and left tibiae.The lower-extremity fractures were treated with provisional unilateral external fixation and prophylactic fasciotomies.The article noted that ¿the patient successfully tolerated progressive tsf dynamization over an 8-week period.¿ following the dynamization, radiographs and scans revealed consolidated callus around the proximal and distal graft inlay sites, which lead to the removal of the frame.The patient reported acute pain and a ¿popping¿ sensation shortly afterward, during physical therapy.Repeat radiographs revealed a fracture across the midportion of the fibular autograft.An open reduction and internal fixation was performed.Two years following this it was documented that the patient experienced continued pain during activity and a stiff and painful ankle and a right transtibial amputation was performed.Without the requested clinical information, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the physician referenced in the abstract provided an analysis of all of the attached images.Therefore, no further interpretation of the attached images are required.No further medical assessment is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure, injury and/or patient condition.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: UNKN TAYLOR SPATIAL FRAME EXFIX DEV
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10960852
• MDR Text Key: 219993244
• Report Number: 1020279-2020-07115
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• 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
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1