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

Catalog Number UNKNOWN

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

"acta orthop traumatol turc 2016.Treatment of infected nonunion of the juxta-articular region of the distal tibia." author: göksel dikmen et al.In this study there were 13 patients, only 1 patient bearing tsf.It was reported that a patient suffered from persisting nonunion after tsf.Kirschner wire breakage occurred at the distal part of the fixator.The event was treated via revision surgery (retrograde intramedullary nail, the distal part of the fixator was replaced).

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms the data presented in the aged article does not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, 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; therefore, no further medical assessment is warranted at this time.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: UNKN TAYLOR SPATIAL FRAME EXFIX DEV
• Type of Device: PIN, FIXATION, THREADED, METALLIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10956059
• MDR Text Key: 219850507
• Report Number: 1020279-2020-07031
• Device Sequence Number: 1
• Product Code: NDM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/06/2020
• Supplement Dates Manufacturer Received: 03/29/2021
• Supplement Dates FDA Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention