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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. OTHER EXFIX DEV; PIN, FIXATION, THREADED Back to Search Results
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.
 
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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 Key10059170
MDR Text Key191110482
Report Number1020279-2020-01720
Device Sequence Number1
Product Code JDW
Combination Product (y/n)N
Number of Events Reported1
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 NumberUNKNOWN
Was Device Available for Evaluation? No
Distributor Facility Aware Date04/15/2020
Initial Date Manufacturer Received 04/15/2020
Initial Date FDA Received05/14/2020
Supplement Dates Manufacturer Received09/18/2020
Supplement Dates FDA Received09/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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