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

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Injury (2348)

Event Date 04/15/2020

Event Type  Injury  

Event Description

"chronic flexion contracture of proximal interphalangeal joint treated with the compass hinge external fixator.A consecutive series of 27 cases".Author: s.Houshian et al., (british and european volume, 2002) 27b: 4: 356¿358.In this study, twenty-seven chronic flexion contractures of the proximal interphalangeal joint were treated with the compass hinge external fixator without open surgery.The fixator was removed after a mean of 33 (range, 14¿68) days.The mean time from injury to operation was 4 (range, 1¿19) years and all patients were reviewed at a mean follow-up of 21 (range, 12¿50) months.The mean extension gain was 381 (range, 0¿701), and the mean flexion¿extension arc improved by 421 (range, 0¿801).It was documented on the paper that superficial pin-track infections occurred in 11 cases, nine of these settled within 7 days with oral antibiotics and local wound care.

Manufacturer Narrative

Results of investigation: it was reported from a literature review that the patient presented superficial pin-track infection.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.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.Based on this investigation, the need for corrective action is not indicated.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: UNKNOWN COMPASS HINGE EXTERNAL FIXATOR
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10029630
• MDR Text Key: 190032136
• Report Number: 1020279-2020-01501
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/15/2020
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention