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

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

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 two cases had failure of the fixator block.

Manufacturer Narrative

It was reported from a literature review that the patient had failure of fixator block.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.The paper was published in 1998 to discuss the treatment of complex fracture dislocation of the proximal interphalangeal joint with dynamic hinged external fixation for injuries.Injuries to the (pip) joint of the finger are common in ball sports.They are caused by hyperextension and axial loading which result in impaction of the volar articular surface of the middle phalanx against the condyles of the proximal phalanx.

• 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: 10059170
• MDR Text Key: 191110482
• Report Number: 1020279-2020-01720
• 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: 09/24/2020

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?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/15/2020
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention