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

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that, after surgery, a pin of a taylor spatial framework failed.A medical/surgical intervention is required to address such events and restore external fixation.The patient outcome is unknown.

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 evaluation concluded that the responses to the clinical information requests were not provided and the s+n device has not been returned for evaluation.The provided photos of the patient¿s right leg with external fixation, were reviewed, however, the root cause of the pin breakage cannot be determined.Therefore, the impact to the patient beyond that which has already been reported, cannot be determined.Should any additional medical information be provided, this compliant will be re-assessed.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 on the joint, injury, infection and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, 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 EXTERNAL FIXATOR PIN
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11059751
• MDR Text Key: 223359340
• Report Number: 1020279-2020-07723
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• PMA/PMN Number: K994143
• 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: 07/15/2021

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: 11/23/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 07/13/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention