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

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

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that in a clinical observation of "posttraumatic proximal tibial growth arrest: a rare injury managed successfully with ring fixators" that unkn external fixation pin (smith & nephew) was applied to 2 patients that presented infection.It is unknown how this complication was treat.

Manufacturer Narrative

H3, h6: 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 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.In addition, the physician referenced in the abstract provided an analysis of all the attached images.Therefore, no further interpretation of the attached images is required.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.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.We consider this investigation closed.

• 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: 11256340
• MDR Text Key: 229532986
• Report Number: 1020279-2021-00786
• 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: 05/07/2021

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
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/30/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention