MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN EXTERNAL FIXATOR PIN; PIN, FIXATION, THREADED, METALLIC

Catalog Number UNKNOWN

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

In the paper: "strategies in trauma and limb reconstruction 2019.Outcomes following treatment of complex tibial fractures with circular external fixation: a comparison between the taylor spatial frame and truelok-hex" author: jaco naude et al.In this study there were 45 patients, 21 bearing tsf.It was reported that a patient suffered from superficial pin infections.It is unknown how the event was treated.

Manufacturer Narrative

The device, used in 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 during the studying it was reported that the patient developed a superficial pin infection.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.Infection, a potential complication associated with any surgery, can occur and possible causes could include but not limited to contamination, patient reaction, and post-operative healing issue.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.Case-2020-00030528-1.

• Brand Name: UNKN EXTERNAL FIXATOR PIN
• Type of Device: PIN, FIXATION, THREADED, METALLIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10967439
• MDR Text Key: 220180068
• Report Number: 1020279-2020-07186
• 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: foreign,literature,study
• Type of Report: Initial,Followup
• Report Date: 03/03/2021

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: 12/08/2020
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1