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

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on literature review ¿taylor spatial frame in treatment of equinus deformity¿, one revision surgery was reported due to a broken fixator half pin while using unkn external fixation pin component.

Manufacturer Narrative

The device, used for treatment, was not returned for evaluation.Therefore, a product analysis could not be performed at this time and the reported event could not be confirmed.A medical investigation was conducted and confirms the data presented in the article, ¿taylor spatial frame in treatment of equinus deformity¿, was reviewed.However, without clinically relevant patient-specific supporting documentation, a thorough medical investigation could not be performed.The images provided in the article have been interpreted within the text; therefore, no further analysis of the images is required.The root cause and/or patient outcome beyond that which was documented in the article could not 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.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: 11267078
• MDR Text Key: 229877090
• Report Number: 1020279-2021-00836
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 02/02/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention