MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OTHER EXFIX DEV; PIN, FIXATION, THREADED

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

"hinged device for fractures involving the proximal interphalangeal joint".Authors: joel d.Krakauer, md and peter j.Stern, md, clinical orthopaedics and related research.The authors of the study reported that 20 patients were treated using smith and nephew compass pip hinge, 12 treated within 2 weeks of injury (group i) and 8 treated more than 4 weeks after injury (group ii), were reported.It was documented on the paper that there was one deep infection 6 days postoperative and the device was removed.

Manufacturer Narrative

It was reported from a literature review that the patient had deep infection 6 days postoperative and the device was removed.The affected complaint device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record, sterilization documentation and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.The physician referenced in the abstract provided an analysis of all of the attached images.Therefore, no further interpretation of the attached images are required.Based on this investigation, the need for corrective action is not indicated.The paper was published in 1996.Infection, a potential complication associated with any surgery, can occur and possible causes could include but are not limited to contamination, patient reaction, and post-operative healing issue.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: OTHER EXFIX DEV
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10059332
• MDR Text Key: 191095717
• Report Number: 1020279-2020-01734
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 10/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/15/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention