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

Lot Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

"the dynamic external fixation for injuries of the proximal interphalangeal joint.".Author: gregory i.Bain et al., the journal of bone & joint surgery (br).In this study, there is also a mention of treatment of complex fracture dislocation of the pip joint with dynamic hinged external fixation which hotchkiss r reported 20 cases of which five were acute.It was documented on the paper that three cases showed gross loosening of the pins.

Manufacturer Narrative

It was reported from a literature review that the patient showed gross loosening of the pins.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 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.Based on this investigation, the need for corrective action is not indicated.The paper was published in 1998.Some potential causes could include but are not limited to traumatic injury, abnormal motion over time or patient medical history.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• 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: 10059180
• MDR Text Key: 191032365
• Report Number: 1020279-2020-01723
• 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: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

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: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention